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Effects of the Diabetes Manual 1 : 1 structured education in primary care
Abstract
To determine the effects of the Diabetes Manual on glycaemic control, diabetes-related distress and confidence to self-care of patients with Type 2 diabetes.
A cluster randomized, controlled trial of an intervention group vs. a 6-month delayed-intervention control group with a nested qualitative study. Participants were 48 urban general practices in the West Midlands, UK, with high population deprivation levels and 245 adults with Type 2 diabetes with a mean age of 62 years recruited pre-randomization. The Diabetes Manual is 1:1 structured education designed for delivery by practice nurses. Measured outcomes were HbA(1c), cardiovascular risk factors, diabetes-related distress measured by the Problem Areas in Diabetes Scale and confidence to self-care measured by the Diabetes Management Self-Efficacy Scale. Outcomes were assessed at baseline and 26 weeks.
There was no significant difference in HbA(1c) between the intervention group and the control group [difference -0.08%, 95% confidence interval (CI) -0.28, 0.11]. Diabetes-related distress scores were lower in the intervention group compared with the control group (difference -4.5, 95% CI -8.1, -1.0). Confidence to self-care Scores were 11.2 points higher (95% CI 4.4, 18.0) in the intervention group compared with the control group. The patient response rate was 18.5%.
In this population, the Diabetes Manual achieved a small improvement in patient diabetes-related distress and confidence to self-care over 26 weeks, without a change in glycaemic control. Further study is needed to optimize the intervention and characterize those for whom it is more clinically and psychologically effective to support its use in primary care.
... The extensive search strategy only identified seven eligible trials, and due to the obvious and substantial heterogeneity in the intervention regimen of these trials, the attempt to quantitatively synthesize the results with meta-analysis failed. Narrative summaries of the results demonstrated inconclusive effects of structured education programs on glycemic control, self-efficacy, self-management behaviors and health-related quality of life among individuals with type 2 diabetes [14][15][16][17][18][19][20][21]. Considering the paucity of eligible structured education programs and the variety in the method of intervention delivery, content, intervener, use of technology and underpinning philosophy of existed trials, further interventions tailored to specific populations are desirable to determine the effectiveness of structured education programs for individuals with type 2 diabetes [8]. ...
... The finding regarding the effectiveness of structured education in lowering HbA1c level was consistent with the results of several previous studies of structured education [15,16,18]. Meanwhile, an equivalent number of previous structured education programs demonstrated contradicting results [14,[19][20][21]. However, the insignificant findings of these studies could be attributed to a low power [20], a ceiling effect (the participants had relatively good glycemic control at baseline) [20,21,48], the utilization of an active comparator [14,17], and an inappropriate time point for intervention initiation (immediate structured education for individuals with newly diagnosed diabetes in the course of intensive medical treatments) [14,17] or model of intervention delivery (self-instructed without supervision) [19]. ...
... Meanwhile, an equivalent number of previous structured education programs demonstrated contradicting results [14,[19][20][21]. However, the insignificant findings of these studies could be attributed to a low power [20], a ceiling effect (the participants had relatively good glycemic control at baseline) [20,21,48], the utilization of an active comparator [14,17], and an inappropriate time point for intervention initiation (immediate structured education for individuals with newly diagnosed diabetes in the course of intensive medical treatments) [14,17] or model of intervention delivery (self-instructed without supervision) [19]. In the development of this program, the methodological flaws were adequately addressed to guarantee its soundness. ...
Background
International guidelines advocate providing prompt structured education to individuals with diabetes at diagnosis. However, among the few eligible structured education programs, heterogeneous intervention regimens and inconsistent findings were reported. Eligible programs for Chinese individuals with diabetes are lacking. This study aimed to investigate the effects of a nurse-led integrative medicine-based structured education program on self-management behaviors, glycemic control and self-efficacy among individuals with newly diagnosed type 2 diabetes.
Methods
Employing a randomized controlled trial, 128 individuals with type 2 diabetes diagnosed in the preceding three to nine months were recruited from four university-affiliated tertiary hospitals in Xi’an City, Northwest China, and randomly allocated to the intervention or control groups after baseline assessments. Participants in the intervention group received a 4-week nurse-led integrative medicine-based structured education program, which is theoretically based on the Health Belief Model and Self-Efficacy Theory, in line with updated diabetes management guidelines, and informed by relevant systematic reviews. Participants in the control group received routine care. Self-management behaviors and self-efficacy were measured with the Summary of Diabetes Self-Care Activities and the Diabetes Management Self-Efficacy Scale at baseline, immediate post-intervention and 12 weeks following the intervention while Glycated Hemoglobin A was measured at baseline and the 12th-week follow-up. The intervention effects were estimated using the generalized estimating equation models.
Results
Participants in the intervention group exhibited significantly better self-management performance in specific diet regarding intake of fruits and vegetables at both follow-ups (β = 1.02, p = 0.011 and β = 0.98, p = 0.016, respectively), specific diet regarding intake of high-fat foods at the immediate post-intervention follow-up (β = 0.83, p = 0.023), blood glucose monitoring at the 12th-week follow-up (β = 0.64, p = 0.004), foot care at both follow-ups (β = 1.80, p < 0.001 and β = 2.02, p < 0.001, respectively), and medication management at both follow-ups (β = 0.83, p = 0.005 and β = 0.95, p = 0.003, respectively). The intervention also introduced significant improvements in Glycated Hemoglobin A (β = − 0.32%, p < 0.001), and self-efficacy at both follow-ups (β = 8.73, p < 0.001 and β = 9.71, p < 0.001, respectively).
Conclusions
The nurse-led integrative medicine-based structured education program could produce beneficial effects on multiple diabetes self-management behaviors, glycemic control and self-efficacy.
Trial registration
This study was retrospectively registered in the ClinicalTrials.gov . on 25/08/2017; registration number: NCT03261895 .
... Four papers [19][20][21][22] reported the impact of the same intervention using various study designs and types of outcomes. Two studies used qualitative methods [23,24], one study used mixed methods [25], 13 studies were randomized controlled trials (RCTs) with up to four arms, and the remaining six studies were cohort studies [19][20][21][22]26,27]. The median publication year was 2015, whilst the most frequent publication year was 2016 (six records). ...
... Cohort studies included up to 24 250 participants [19]. Most of the included studies had more than one outcome; outcomes were sometimes categorized as primary and secondary [25,28,[31][32][33][34][35][36], although most studies did not make this distinction. Table 2 summarizes the patient-centred approaches used in the studies, including person-centred theories/values/mechanisms, applied methods and tools, and healthcare professional (HCP) training. ...
... The study did not include psychosocial outcomes, but identified intrinsic motivation as a pathway to behaviour change. In qualitative analyses by Sturt et al. [25], some participants reported positive outcomes in terms of increased self-efficacy, attitudinal changes and new or reinforced diabetes knowledge. ...
Aims:
To synthesize primary research into the impact of person-centred diabetes self-management education, and support that targets people with type 2 diabetes, on behavioural, psychosocial and cardiometabolic outcomes and to identify effective mechanisms underlying positive outcomes of person-centred diabetes self-management education and support.
Methods:
Using Whittemore and Knafl's integrative review method, we conducted a systematic search of peer-reviewed literature published between January 2008 and June 2019 using PubMed, Scopus and CINAHL. After article selection according to established criteria, study quality was assessed using Critical Appraisal Skills Programme checklists for cohort studies, randomized controlled trials and qualitative research.
Results:
From 1901 identified records, 22 (19 quantitative, two qualitative, and one mixed methods) were considered eligible for inclusion. Interventions were categorized by content, medium of delivery, and outcomes. Qualitative studies, quantitative cohort studies and randomized controlled trials demonstrated positive outcomes, with no differences in success rates across study design. Interventions were largely successful in improving HbA1c and patient-reported outcomes such as quality of life but had limited success in lowering cholesterol and weight, or initiating long-term improvements in lifestyle behaviours. Primary objectives were achieved more often than secondary objectives, and studies with fewer outcomes appeared more successful in achieving specific outcomes.
Conclusions:
Person-centred diabetes self-management education and support has demonstrated a considerable impact on desired diabetes-related outcomes in people with type 2 diabetes. To advance the field further, new studies should take advantage of systematic and transparent approaches to person-centred diabetes self-management education.
... Those not reporting the objective outcomes at any follow-ups were considered to have unclear risk. The risk of bias due to incomplete outcome data was considered high in four studies (Sturt et al. 2008, Mohamed et al. 2013, Mash et al. 2014, Steed et al. 2014, because the amount of missing data was large or not appropriately handled or having significance difference between completers and dropouts. For the remaining studies the risk of bias was low or unclear. ...
... Eight studies (Toobert et al. 2003, Deakin et al. 2006, Adolfsson et al. 2007, Sturt et al. 2008, Thoolen et al. 2009, Partapsingh et al. 2011, Mohamed et al. 2013, Beverly et al. 2013 in the meta-analysis suggested that theorybased interventions did not seem to reduce BMI compared with routine care. One study did not show the data required (Sturt et al. 2008). ...
... Eight studies (Toobert et al. 2003, Deakin et al. 2006, Adolfsson et al. 2007, Sturt et al. 2008, Thoolen et al. 2009, Partapsingh et al. 2011, Mohamed et al. 2013, Beverly et al. 2013 in the meta-analysis suggested that theorybased interventions did not seem to reduce BMI compared with routine care. One study did not show the data required (Sturt et al. 2008). The pooled WMD was À0Á53, 95% CI [À1Á11, 0Á05]; Z = 1Á79, P = 0Á073, I 2 = 0%; Figure 4a). ...
Aim:
To synthesize the effects of theory-based self-management educational interventions on patients with type 2 diabetes (T2DM) in randomized controlled trials.
Background:
Type 2 diabetes is a common chronic disease causing complications that put a heavy burden on society and reduce the quality of life of patients. Good self-management of diabetes can prevent complications and improve the quality of life of T2DM patients.
Design:
Systematic review with meta-analysis of randomized controlled trials following Cochrane methods.
Data resources:
A literature search was carried out in the MEDLINE, EMBASE, CINAHL, PSYCINFO, and Web of Science databases (1980-April 2015).
Review methods:
The risk of bias of these eligible studies was assessed independently by two authors using the Cochrane Collaboration's tool. The Publication bias of the main outcomes was examined. Statistical heterogeneity and random-effects model were used for meta-analysis.
Results:
Twenty studies with 5802 participants met the inclusion criteria. The interventions in the studies were based on one or more theories which mostly belong to mid-range theories. The pooled main outcomes by random-effects model showed significant improvements in HbA1c, self-efficacy, and diabetes knowledge, but not in BMI. As for quality of life, no conclusions can be drawn as the pooled outcome became the opposite with reduced heterogeneity after one study was excluded. No significant publication bias was found in the main outcomes.
Conclusion:
To get theory-based interventions to produce more effects, the role of patients should be more involved and stronger and the education team should be trained beyond the primary preparation for the self-management education program.
... Of the remaining eight CRCTs, two CRCTs [39,47] used multiple outcomes and calculated sample sizes for each outcome of relevance. Seven CRCTs [14,39,[47][48][49][50][51] used HbA1c as an outcome measure, three [38,39,47] used systolic blood pressure, and two [39,47] used cholesterol. However, cholesterol was not used as a sole outcome measure, only as secondary measure alongside both HbA1c and blood pressure. ...
... However, cholesterol was not used as a sole outcome measure, only as secondary measure alongside both HbA1c and blood pressure. Of these eight CRCTs, two [38,39] used a binary outcome, and seven [14,39,[47][48][49][50][51] used a continuous outcome (one used both a binary and continuous outcome [39]). ...
... The results of this paper found a similar standard deviation of 1.4 for HbA1c %, whereas the ICC found by this paper was lower (0.032 versus 0.047). Only three trials reported ICCs from their analysis [14,38,48]. Two trials reported ICCs for HbA1c % [14,48], with ICCs of 0.0253 and 0.02 (95 % CI 0.00-0.08), ...
Background
Clustered randomised controlled trials (CRCTs) are increasingly common in primary care. Outcomes within the same cluster tend to be correlated with one another. In sample size calculations, estimates of the intra-cluster correlation coefficient (ICC) are needed to allow for this nonindependence. In studies with observations over more than one time period, estimates of the inter-period correlation (IPC) and the within-period correlation (WPC) are also needed. Methods
This is a retrospective cross-sectional study of all patients aged 18 or over with a diagnosis of type-2 diabetes, from The Health Improvement Network (THIN) database, between 1 October 2007 and 31 March 2010. We report estimates of the ICC, IPC, and WPC for typical outcomes using unadjusted and adjusted generalised linear mixed models with cluster and cluster by period random effects. For binary outcomes we report on the proportions scale, which is the appropriate scale for trial design. Estimated ICCs were compared to those reported from a systematic search of CRCTs undertaken in primary care in the UK in type-2 diabetes. ResultsData from 430 general practices, with a median [IQR] number of diabetics per practice of 241 [150–351], were analysed. The ICC for HbA1c was 0.032 (95 % CI 0.026–0.038). For a two-period (each of 12 months) design, the WPC for HbA1c was 0.035 (95 % CI 0.030–0.040) and the IPC was 0.019 (95 % CI 0.014–0.026). The difference between the WPC and the IPC indicates a decay of correlation over time. Following dichotomisation at 7.5 %, the ICC for HbA1c was 0.026 (95 % CI 0.022–0.030). ICCs for other clinical measurements and clinical outcomes are presented. A systematic search of ICCs used in the design of CRCTs involving type-2 diabetes with HbA1c (undichotomised) as the outcome found that published trials tended to use more conservative ICC values (median 0.047, IQR 0.047–0.050) than those reported here. Conclusions
These estimates of ICCs, IPCs, and WPCs for a variety of outcomes commonly used in diabetes trials can be useful for the design of CRCTs. In studies with observations taken at different time-points, the correlation of observations may decay over time, as reflected in lower values for the IPC than for the ICC. The IPC and WPC estimates are the first reported for UK primary care data.
... Follow-up A1C results of greater than 3 months duration were reported for 11,584 IG participants and 10,466CG participants. A total of 73 (61.9%) unique interventions demonstrated significant differences between the IG and CG [14,18,19,22,24,50,51,54,[56][57][58][59][61][62][63][64]67,69,74,76,77,79,81,82,[84][85][86][87][88][89][90][91][92][93][94][95][96][97][98]101,102,106,108,[110][111][112][113][114]117,119,[125][126][127][128]130,[132][133][134]136,137,139,[141][142][143]146,149,150,153,154] compared with 45 (38.1%) interventions that resulted in no significant differences (Table 1) [20,[47][48][49][51][52][53]55,60,65,66,68,[70][71][72][73]75,78,80,83,99,100,[103][104][105]109,118,[120][121][122][123][124]129,131,135,138,140,144,151,152]. ...
... Interventions differed with respect to a number of factors with potential to impact outcomes such as clinical and demographic characteristics of participants; mode of DSME delivery, DSME provider, estimated maximum duration and maximum contact hours; frequency and duration of follow-up assessments; and quality (Table 1). Individual DSME was delivered in 49 (41.5%) of the studies [20,24,[47][48][49][50][51]56,[58][59][60][61]69,71,[74][75][76]80,81,87,88,[91][92][93]96,97,99,104,106,107,109,110,[116][117][118]120,122,128,129,131,132,142,144,149,151], with 35 (29.7%) administering the intervention in a group setting [18,50,51,53,55,57,62-64,66-68,77,78,83,86,89,94,100,102,103,105,112,113,133,135-137, 140,143,146,150,152-154], 21(17.8%) providing DSME as a combination of individual and group education [14,19,22,47,48,54,79,82,85,90,98,101,108,111,115,124,126,127,130,139,141], and 10.2% engaging people primarily through remote education [65,70,72,73,84,114,119,121,123,125,134,138]. ...
... One study did not report the mode of DSME delivery [95]. Single DSME providers were used in 71 (60.2%) of interventions [48,49,54,56,[58][59][60][61]63,[65][66][67]69,70,[72][73][74][75][76]78,80,81,[83][84][85][86][88][89][90][91][93][94][95][96][97][98][99][104][105][106]108,109,111,114,115,[118][119][120][121][122][123][125][126][127][128][129]131,[133][134][135][136]138,141,142,144,150,152] and 46 (39.0%) studies [14,[18][19][20]22,24,47,[50][51][52][53][54][55]57,62,64,68,71,77,79,87,92,[100][101][102][103]107,110,112,113,116,117,124,130,132,137,140,143,149,151,153,154] provided team-based DSME. One study did not report the provider of DSME. ...
Objective:
Assess effect of diabetes self-management education and support methods, providers, duration, and contact time on glycemic control in adults with type 2 diabetes.
Method:
We searched MEDLINE, CINAHL, EMBASE, ERIC, and PsycINFO to December 2013 for interventions which included elements to improve participants' knowledge, skills, and ability to perform self-management activities as well as informed decision-making around goal setting.
Results:
This review included 118 unique interventions, with 61.9% reporting significant changes in A1C. Overall mean reduction in A1C was 0.74 and 0.17 for intervention and control groups; an average absolute reduction in A1C of 0.57. A combination of group and individual engagement results in the largest decreases in A1C (0.88). Contact hours ≥10 were associated with a greater proportion of interventions with significant reduction in A1C (70.3%). In patients with persistently elevated glycemic values (A1C>9), a greater proportion of studies reported statistically significant reduction in A1C (83.9%).
Conclusions:
This systematic review found robust data demonstrating that engagement in diabetes self-management education results in a statistically significant decrease in A1C levels.
Practice implications:
The data suggest mode of delivery, hours of engagement, and baseline A1C can affect the likelihood of achieving statistically significant and clinically meaningful improvement in A1C.
... Self-Management Education (DSME) is advocated for people with diabetes by major diabetes organisations across the developed world. 1-4 Outcomes of DSME trials have been equivocal with most programmes demonstrating some effect on a range of outcomes including glycaemic control, 5 6 smoking cessation and illness beliefs, 7 diabetes distress and self-efficacy, 8 and quality of life. 6 However, not all have demonstrated effects on the outcome of greatest clinical importance, namely glycaemic control. ...
... 6 However, not all have demonstrated effects on the outcome of greatest clinical importance, namely glycaemic control. [7][8][9] This has contributed to variability in healthcare professionals' (HCPs) views of DSME, and the extent to which DSME is commissioned and delivered in health economies. 2 UK National Institute for Health and Care Excellence (NICE) guidance advocates DSME (which in the UK is generally referred to as Diabetes Strengths and limitations of the study ▪ Thirteen diabetes-related clinical, behavioural and psychological outcomes were assessed for each participant. ...
... Self-efficacy is modifiable by DSME. 8 People with low self-efficacy might be expected to raise this following DSME ...
Objective To predict the diabetes-related outcomes of people undertaking a type 2 Diabetes Self-Management Education (DSME) programme from their baseline data.
Design A mixed-methods longitudinal experimental study. 6 practice nurses and 2 clinical academics undertook blind assessments of all baseline and process data to predict clinical, behavioural and psychological outcomes at 6 months post-DSME programme.
Setting Primary care.
Participants –31 people with type 2 diabetes who had not previously undertaken DSME.
Intervention All participants undertook the Diabetes Manual 1:1 self-directed learning 12-week DSME programme supported by practice nurses trained as Diabetes Manual facilitators.
Outcome variables Glycated haemoglobin (HbA1c), diabetes knowledge, physical activity, waist circumference, self-efficacy, diabetes distress, anxiety, depression, demographics, change talk and treatment satisfaction. These variables were chosen because they are known to influence self-management behaviour or to have been influenced by a DSME programme in empirical evidence.
Results Baseline and 6-month follow-up data were available for 27 participants of which 13 (48%) were male, 22 (82%) white British, mean age 59 years and mean duration of type 2 diabetes 9.1 years. Significant reductions were found in HbA1c t(26)=2.35, p=0.03, and diabetes distress t(26)=2.30, p=0.03, and a significant increase in knowledge t(26)=−2.06, p=0.05 between baseline and 6 months. No significant changes were found in waist circumference, physical activity, anxiety, depression or self-efficacy. Accuracy of predictions varied little between clinical academics and practice nurses but greatly between outcome (0–100%). The median and mode accuracy of predicted outcome was 66.67%. Accuracy of prediction for the key outcome of HbA1c was 44.44%. Diabetes distress had the highest prediction accuracy (81.48%).
Conclusions Clinicians in this small study were unable to identify individuals likely to achieve improvement in outcomes from DSME. DSME should be promoted to all patients with diabetes according to guidelines.
... By using 80% power and alpha of 0.05, the minimum samples obtained without cluster correction were 32 subjects for each group. Then, taking into account the design effect 1 + ( (m + 1) using cluster size 30 and Inter-cluster Correlation Coefficient (ICC) = 0.043 based on manual diabetic research [20]. The design effect formula accounted for m number of observations in each cluster and (rho) is the intra-cluster correlation. ...
... Outcome related psychological data obtained in this study, including children's attitude, subjective norm, perceived behavioral control, behavior, and intention toward fish consumption. All of the psychological data questionnaires were developed as Likert scale answers based on Bandura's guide for constructing attitude, subjective norm, perceived behavioral control, behavior, and intention scales [20]. Children's attitude to consuming fish as the source of animal protein was measured using a three-item questionnaire (e.g., attitude toward increasing food consumption, attitude towards consuming fish at least twice a week, and attitude toward consuming fish every day). ...
This study aimed to analyze the effectiveness of behavioral-based nutrition education to increase fish consumption among school children using a raised bed pool. This was a randomized control trial study with a 3-months nutrition education intervention using a raised bed pool, as a medium to improve their internalization to increase fish consumption behavior. A paired t-test was used to calculate the difference in the increase of fish consumption, knowledge, attitude, perceived behavioral control, subjective norm, and intention. This study took place in a majority of low to medium urban households in Surabaya in Sidotopo Wetan I and Sidotopo Wetan II elementary school. Elementary school children at 4th and 5th grade and mother of elementary school children with 104 children were eligible and willing to participate. After the completion of interventions, significant improvement in delta-mean and effectiveness observed in attitude, subjective norm, perceived behavioral control, intention, knowledge, and fish consumption (p < 0.001). The 3 months of nutrition education intervention based on the theory of planned behavior significantly increase fish consumption among elementary school children. The increased consumption was believed to be related to the increase in children's knowledge and attitude towards consuming fish.
... Outcome-related psychological data were obtained in this study, including mother's attitude, subjective norm, perceived behavioral control, self-efficacy, and intention toward giving nutritious complementary feeding. All of the psychological data questionnaires were developed as Likert-scale answers based on Bandura's guide for constructing attitude, subjective norm, perceived behavioral control, self-efficacy, and intention scales [21]. Except for self-efficacy, all variables were scored using a Likert scale from 1 to 7, in which 1 represents "strongly disagree" and 7 represents "strongly agree." ...
Complementary feeding should be given to infants at 6 months in addition to breastmilk. Mothers’ knowledge and behavior in giving adequate complementary feeding are crucial to prevent malnutrition risk. During the pandemic, conventional nutrition education cannot be maintained and could lead to decreased mothers’ knowledge. This study is aimed at analyzing the effectiveness of nutrition education using online digital platforms (WhatsApp) to improve a mother’s behavior in providing nutritious complementary food based on the theory of planned behavior approach. This was a quasiexperiment with one pretest and posttest design group in the form of education and counselling. Ten educational sessions were developed to improve one or more TPB constructs. Media used for education are PowerPoint, text description, posters, and video tutorials; it is implemented by sending materials through the WhatsApp application. Using 80% power, the sample size was calculated for 155 subjects. Subjects were recruited through the accidental sampling method. Data was collected by the online method using a validated open-ended self-developed questionnaire for knowledge, while attitude, subjective norms, intention, and self-efficacy were measured using a Likert-scale questionnaire, where participants rated the strength of their belief that they could engage in a specific task. The paired t-test was used to analyze the difference in outcomes measured. The response rate of this study was accounted for at 77.5%. The mean age of mothers was 28.2 years old; most of them were university graduates (80.2%) and working as private sector workers (40.0%). The average child’s age was 6.6 months old. 78.2% of children were exclusively breastfed. Our study revealed that 10 sessions of nutrition education and counselling covered over 8 days increased the mother’s knowledge (60.0±15.5 vs. 80.3±15.0, respectively, before and after education; p
... The most frequently reported socioeconomic characteristics were education level and employment status [37][38][39]. The UK Diabetes Manual trial enrolled patients from practices in anurban multiethnic and socioeconomically deprived population, with a retention rate of 72% in the intervention group and 85% in the control group at six months [40]. ...
Abstract Background Diabetes self-management education is exposed to attrition from services and structured ambulatory care. However, knowledge about factors related to attrition in educational programs remains limited. The context of social vulnerability due to low income may interfere. The aim of this study was to identify the sociodemographic, clinical, psychometric, and lifestyle factors associated with attrition from the ERMIES multicentre randomized parallel controlled trial (RCT) that was interrupted due to the combination of both slow inclusion and high attrition. Methods The ERMIES trial was performed from 2011 to 2016 on Reunion Island, which is characterized by a multicultural population and high social vulnerability. The original objective of the RCT was to test the efficacy of a2-year structured group self-management education in improving blood glucose in adult patients with nonrecent, insufficiently controlled type 2 diabetes. One hundred participants were randomized to intensive educational intervention maintained over two years (n = 51) versus only initial education (n = 49). Randomization was stratified on two factors: centres (five strata) and antidiabetic treatment (two strata: insulin-treated or not). Sociodemographic, clinical, health-care access and pathway, psychometric and lifestyle characteristics data were collected at baseline and used to assess determinants of attrition in a particular social context and vulnerability. Attrition and retention rates were measured at each visit during the study. Multiple correspondence analysis and Cox regression were performed to identify variables associated with attrition. Results The global attrition rate was 26% during the study, with no significant difference between the two arms of randomization (9 dropouts out of 51 patients in the intervention group and 17 out of 49 in the control group). Male gender, multiperson household, low household incomes (
... Self-management interventions for people with T2DM are typically delivered through face-to-face or group-based courses [5][6][7]. Although these interventions can improve clinical and psychosocial outcomes in people with T2DM [8] and are cost-effective [9], attendance can be extremely low. ...
Background
“Healthy Living for People with type 2 Diabetes (HeLP-Diabetes)” was a theory-based digital self-management intervention for people with type 2 diabetes mellitus that encouraged behavior change using behavior change techniques (BCTs) and promoted self-management. HeLP-Diabetes was effective in reducing HbA1c levels in a randomized controlled trial (RCT). National Health Service (NHS) England commissioned a national rollout of HeLP-Diabetes in routine care (now called “Healthy Living”). Healthy Living presents a unique opportunity to examine the fidelity of the national rollout of an intervention originally tested in an RCT.
Objective
This research aimed to describe the Healthy Living BCT and self-management content and features of intervention delivery, compare the fidelity of Healthy Living with the original HeLP-Diabetes intervention, and explain the reasons for any fidelity drift during national rollout through qualitative interviews.
Methods
Content analysis of Healthy Living was conducted using 3 coding frameworks (objective 1): the BCT Taxonomy v1, a new coding framework for assessing self-management tasks, and the Template for Intervention Description and Replication. The extent to which BCTs and self-management tasks were included in Healthy Living was compared with published descriptions of HeLP-Diabetes (objective 2). Semistructured interviews were conducted with 9 stakeholders involved in the development of HeLP-Diabetes or Healthy Living to understand the reasons for any changes during national rollout (objective 3). Qualitative data were thematically analyzed using a modified framework approach.
Results
The content analysis identified 43 BCTs in Healthy Living. Healthy Living included all but one of the self-regulatory BCTs (“commitment”) in the original HeLP-Diabetes intervention. Healthy Living was found to address all areas of self-management (medical, emotional, and role) in line with the original HeLP-Diabetes intervention. However, 2 important changes were identified. First, facilitated access by a health care professional was not implemented; interviews revealed this was because general practices had fewer resources in comparison with the RCT. Second, Healthy Living included an additional structured web-based learning curriculum that was developed by the HeLP-Diabetes team but was not included in the original RCT; interviews revealed that this was because of changes in NHS policy that encouraged referral to structured education. Interviewees described how the service provider had to reformat the content of the original HeLP-Diabetes website to make it more usable and accessible to meet the multiple digital standards required for implementation in the NHS.
Conclusions
The national rollout of Healthy Living had good fidelity to the BCT and self-management content of HeLP-Diabetes. Important changes were attributable to the challenges of scaling up a digital intervention from an RCT to a nationally implemented intervention, mainly because of fewer resources available in practice and the length of time since the RCT. This study highlights the importance of considering implementation throughout all phases of intervention development.
... In the UK, NICE guidelines recommend provision of structured self-management education (SSME) to individuals with T2DM [5]. This can take the form of group sessions (for example, DES-MOND [6,7] or XPERT [8]), one-to-one counselling, or other modalities (such as the Diabetes Manual [9][10][11]), ideally meeting national quality standards [12]. ...
Background
Referral and uptake rates of structured self-management education (SSME) for Type 2 diabetes (T2DM) in the UK are variable and relatively low. Research has documented contributing factors at patient, practitioner and organisational levels. We report a project to develop an intervention to improve referral to and uptake of SSME, involving an integrative synthesis of existing datasets and stakeholder consultation and using Normalisation Process Theory (NPT) as a flexible framework to inform the development process.
Methods
A three-phase mixed-methods development process involved: (1) synthesis of existing evidence; (2) stakeholder consultation; and (3) intervention design. The first phase included a secondary analysis of data from existing studies of T2DM SSME programmes and a systematic review of the literature on application of NPT in primary care. Influences on referral and uptake of diabetes SSME were identified, along with insights into implementation processes, using NPT constructs to inform analysis. This gave rise to desirable attributes for an intervention to improve uptake of SSME. The second phase involved engaging with stakeholders to prioritise and then rank these attributes, and develop a list of associated resources needed for delivery. The third phase addressed intervention design. It involved translating the ranked attributes into essential components of a complex intervention, and then further refinement of components and associated resources.
Results
In phase 1, synthesised analysis of 64 transcripts and 23 articles generated a longlist of 46 attributes of an embedded SSME, mapped into four overarching domains: valued, integrated, permeable and effectively delivered. Stakeholder engagement in phase 2 progressed this to a priority ranked list of 11. In phase 3, four essential components attending to the prioritised attributes and forming the basis of the intervention were identified: 1) a clear marketing strategy for SSME; 2) a user friendly and effective referral pathway; 3) new/amended professional roles; and 4) a toolkit of resources.
Conclusions
NPT provides a flexible framework for synthesising evidence for the purpose of developing a complex intervention designed to increase and reduce variation in uptake to SSME programmes in primary care settings.
... A typical example for diabetes is the challenge with the delivery of appropriate and effective diabetes self-management education (DSME) to vulnerable populations. Multiple studies have found that diabetes DSME is associated with improved diabetes knowledge and self-care behavior [9], improved clinical outcomes such as lower hemoglobin A 1c [10], lower self-reported weight [11,12], improved quality of life [13], healthy coping [13,14], and lower costs [15]. Diabetes education is associated with increased use of primary and preventive services and lower use of acute, inpatient hospital services [16], and patients who participate in DSME are more likely to follow best practice treatment recommendations, particularly among the Medicare population. ...
Background:
A critical unmet need for underserved patients with diabetes is regular access to sufficient support for diabetes self-management. Although advances in digital technologies have made way for eHealth applications that provide a scalable path for tailored interventions for self-management of chronic conditions, health and digital literacy has remained an obstacle to leveraging these technologies for effective diabetes self-management education. Studies have shown that the availability of coaches helps to maintain engagement in internet-based studies and improves self-efficacy for behavior change. However, little is known about the substances involved in these interactions.
Objective:
This study aims to compare the content of conversations between patient-coach pairs that achieved their self-management goals and those that did not. The context is a clinical implementation study of diabetes self-management behavior change using Health360x within the practices of the Morehouse Choice Accountable Care Organization in the Atlanta metro area. Health360x is a coach-assisted consumer health information technology designed to support self-management skills acquisition and behavior among underserved, high-risk patients with diabetes.
Methods:
We provide a novel analysis of the discursive emphasis on patients and coaches. We examined transcripts of visits using a structural topic model to estimate topic content and prevalence as a function of patient and coach characteristics. We compared topics between patient-coach pairs that achieved diabetes-related self-management goals and those who did not. We also estimated a regression in which utterances are the units, the dependent variable is the proportion of an utterance that is about a given topic, and the independent variables are speaker types and explored other themes.
Results:
Transcripts from 50 patients who were recruited and consented, starting in February 2015, were analyzed. A total of 44 topics were estimated for patient-coach pairs that achieved their intended health goals and 50 topics for those who did not. Analysis of the structural topic model results indicated that coaches in patient-coach pairs that were able to achieve self-management goals provided more contextual feedback and probed into patients' experience with technology and trust in consumer information technologies. We also found that discussions around problem areas and stress, support (βCoach=.015; P<.001), initial visits (βCoach=.02; P<.001), problems with technology (βCoach=.01; P<.001), health eating goals (βCoach=.01; P=.04), diabetes knowledge (βCoach=.02; P<.001), managing blood sugar (βCoach=.03; P<.001), and using Health360x (βCoach=.003; P=.03) were dominated by coaches.
Conclusions:
Coach-facilitated, technology-based diabetes self-management education can help underserved patients with diabetes. Our use of topic modeling in this application sheds light on the actual dynamics in conversations between patients and coaches. Knowledge of the key elements for successful coach-patient interactions based on the analysis of transcripts could be applied to understanding everyday patient-provider encounters, given the recent paradigm shift around the use of telehealth.
... The interventional studies were conducted of the 39 different countries: Sixty from North America (USA [12,31,36,37,39,[41][42][43], Canada [93][94][95], Mexico [96]), twenty nine were from Europe (UK [9,[97][98][99][100][101][102], Netherlands [103][104][105][106], Spain [33,35,107,108], Norway [109,110], Sweden [111,112], Turkey [113,114], Belgium [115], Cyprus [116], Finland [117], Germany [118], Greece [119], Iceland [120], Georgia [32], Italy [11]), twenty seven were from the Western Pacific (Australia [44,[121][122][123], China [124][125][126][127][128][129][130][131], Korea [132][133][134][135], Hong Kong [136,137], Indonesia [138,139], Japan [140], Philippines [141,142], Taiwan [13,29], Thailand [143,144]), seventeen were from the Middle East and North Africa (Qatar [145], Saudi Arabia [146], Jordan [30,147], Iran [40,[148][149][150][151][152][153][154][155][156][157][158], Iraq [28]), four were from Africa (Kenya [159], Mali [160], Ethiopia [161], South Africa [162]), four were from South America (Brazil [163][164][165][166]), and one was from South-East Asia (India [167]) (Supplement section Tables B1 & B2). ...
Aims
Attributes that operationally conceptualize diabetes self-management education (DSME) interventions have never been studied previously to assess their impact on relevant outcomes of interest in people with type 2 diabetes (T2D). The aim of this study was to determine the impact of existing interventions classified by their delivery of skills or information related attributes on immediate (knowledge), intermediate (physical activity), post-intermediate (HbA1c), and long-term (quality of life) outcomes in people with T2D.
Methods
PubMed, Embase, PsycINFO, and Cochrane Library/Cochrane CENTRAL as well as the grey literature were searched to identify interventional studies that examined the impact of DSME interventions on the four different outcomes. Eligible studies were selected and appraised independently by two reviewers. A meta-regression analysis was performed to determine the impact of delivery of the skills- and information-related attributes on the chosen outcomes.
Results
142 studies (n = 25,511 participants) provided data, of which 39 studies (n = 5278) reported on knowledge, 39 studies (n = 8323) on physical activity, 99 studies (n = 17,178) on HbA1c and 24 studies (n = 5147) on quality of life outcomes. Meta-regression analyses demonstrated that skills-related attributes had an estimated effect suggesting improvement in knowledge (SMD [standardized mean difference] increase of 0.80; P = 0.025) and that information-related attributes had an estimated effect suggesting improvement in quality of life (SMD increase of 0.96; P = 0.405). Skill- and information-related attributes did not have an estimated effect suggesting improvement in physical activity or in HbA1c.
Conclusions
The study findings demonstrate that the skills and information related attributes contribute to different outcomes for people with T2D. This study provides, for the first time, preliminary evidence for differential association of the individual DSME attributes with different levels of outcome.
... Moreover, due to the inherent nature of these studies, there was no blinding of participants or programme providers. In over 75% of the studies, there was either a high risk of other biases being present or doubts in this respect, the most common such occurrences being the presence of recruitment bias in trials that were randomised by clusters (Adachi et al., 2010;Mash et al., 2014;Sönnichsen et al., 2010;Wattana et al., 2007) or the existence of contamination between participants in IG and CG (Sturt et al., 2008;Wattana et al., 2007). However, less than 25% of the studies presented a high risk of attrition or reporting bias (Figures 2 and 3). ...
Aims and objectives:
To evaluate the effectiveness of self-care programmes in type 2 diabetes mellitus (T2DM) population in primary health care.
Background:
The impact of educational interventions on T2DM has been evaluated in various contexts, but there is uncertainty about their impact in that of primary care.
Design:
Systematic review and meta-analysis.
Methods:
A search was conducted in PubMed, CINAHL, WOS and Cochrane databases for randomised controlled trials carried out in the period January 2005-December 2017, including studies with at least one face-to-face educational interventions. The quality of the evidence for the primary outcome was evaluated using the GRADE System. A meta-analysis was used to determine the effect achieved although only the results classified as critical or important were taken into consideration. Checklist of Preferred Reporting Items for Systematic Reviews and Meta-analyses has been followed. PROSPERO registration Number: CRD42016038833.
Results:
In total, 21 papers (20 studies) were analysed, representing a population of 12,018 persons with T2DM. For the primary outcome, HbA1 c, the overall reduction obtained was -0.29%, decreasing the effect in long-term follow-up. The quality of the evidence was low/very low due to very serious risk of bias, inconsistency and indirectness of results. Better results were obtained for individual randomised trials versus cluster designs and in those programmes in which nurses leaded the interventions. The findings for other cardiovascular risk factors were inconsistent.
Conclusions:
Educational interventions in primary care addressing T2DM could be effective for metabolic control, but the low quality of the evidence and the lack of measurement of critical results generates uncertainty and highlights the need for high-quality trials.
Relevance to clinical practice:
Most of self-care programmes for T2DM in primary care are focused on metabolic control, while other cardiovascular profile variables with greater impact on mortality or patient-reported outcomes are less intensely addressed.
... Structured self-management education (SSME) for T2DM has been shown to be both beneficial and costeffective [5][6][7][8]. Programmes such as DESMOND [6,7], X-PERT [8] and the Diabetes Manual [9][10][11], have shown SSME to be associated with improved biomedical (e.g. HbA1c, lipids, weight, blood pressure), psychosocial (e.g. ...
Background:
Approximately 425 million people globally have diabetes, with ~ 90% of these having Type 2 Diabetes Mellitus (T2DM). This is a condition that leads to a poor quality of life and increased risk of serious health complications. Structured self-management education (SSME) has been shown to be effective in improving glycaemic control and patient related outcome measures and to be cost-effective. However, despite the demonstrated benefits, attendance at SSME remains low. An intervention has been developed to embed SSME called the 'Embedding Package'. The intervention aims to address barriers and enhance enablers to uptake of SSME at patient, healthcare professional and organisational levels. It comprises a marketing strategy, user friendly and effective referral pathways, new roles to champion SSME and a toolkit of resources.
Methods:
A mixed methods study incorporating a wait-list cluster randomised trial and ethnographic study, including 66 UK general practices, will be conducted with two intervention start times (at 0 and 9 months), each followed by an active delivery phase. At 18 months, the intervention will cease to be actively delivered and a 12 month observational follow-up phase will begin. The intervention, the Embedding Package, aims to increase SSME uptake and subsequent improvements in health outcomes, through a clear marketing strategy, user friendly and effective referral pathways, a local clinical champion and an 'Embedder' and a toolkit of resources for patients, healthcare professionals and other key stakeholders. The primary aim is, through increasing uptake to and attendance at SSME, to reduce HbA1c in people with T2DM compared with usual care. Secondary objectives include: assessing whether there is an increase in referral to and uptake of SSME and improvements in biomedical and psychosocial outcomes; an assessment of the sustainability of the Embedding Package; contextualising the process of implementation, sustainability of change and the 'fit' of the Embedding Package; and an assessment of the cost-effectiveness of the Embedding Package.
Discussion:
This study will assess the effectiveness, cost-effectiveness and sustainability of the Embedding Package, an intervention which aims to improve biomedical and psychosocial outcomes of people with T2DM, through increased referral to and uptake of SSME.
Trial registration:
International Standard Randomised Controlled Trials Number ISRCTN23474120. Assigned 05/04/2018. The study was prospectively registered. On submission of this manuscript practice recruitment is complete, participant recruitment is ongoing and expected to be completed by the end of 2019.
... With respect to glycemic control, the present study shows that both groups attained similar mean HbA1c levels at 4 and 8 months. As already stated, the HbA1c levels at baseline, [30][31][32]. On the contrary, telephone contacts as a means of reinforcement of a previous educational program do not appear to have an additional effect on the HbA1c levels [33]. ...
Introduction
Systematic patient education has been reported to improve adherence to treatment, leading to better clinical outcomes. This cluster randomized real-world study investigated the effect of a systematic education program and telephone support on self-reported adherence to oral glucose-lowering treatment in patients with type 2 diabetes mellitus (T2DM).
Methods
Centers were randomized (1:1) to provide either standard-of-care (control group) or standard-of-care along with the education program and telephone support (empowerment group). Adherence to treatment and satisfaction with treatment were assessed using the four-item Morisky Medication Adherence Scale (MMAS-4) and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). The study population included 457 patients (258/199 male/female) with T2DM and non-optimal glycemic control, on oral antidiabetic treatment (age 62.7 [11.4]; disease duration 8.5 [6.5] years).
Results
MMAS-4 high adherence rates for the control and empowerment groups were increased by 3.8% and 16.8% at 4 months (Breslow-Day test p = 0.04) and by 8.5% and 18.8% at 8 months of follow-up, respectively (Breslow-Day test p = 0.09), compared to baseline. Intense physical activity was increased in both control and empowerment groups by 2.3% and 13.9% at 4 months (Breslow-Day test p = 0.082) and by 4.0% and 22.5% at 8 months of follow-up (Breslow-Day test p < 0.001). Baseline mean (SD) HbA1c was significantly lower in the control group compared with the empowerment group [7.7% versus 8.0%, p = 0.001] and decreased in both groups at 4 months by 0.7% and 0.9%, respectively. The change from baseline in the mean DTSQ status score at 4 months was greater in the empowerment group, and the effect was sustained at 8 months (control group: 29.1, 30.5, and 30.9; empowerment group: 25.0, 28.7, and 29.4 at baseline, 4 and 8 months, respectively, p < 0.001).
Conclusion
Systematic education combined with telephone support delivered by physicians might be associated with improvement in treatment adherence and treatment satisfaction in patients with T2DM.
Funding
MSD, Greece.
... 2008, Kennedy mfl. 2007, tilbud for personer med diabetes type 2 (Sturt 2008, Wattana mfl. 2007), kols (Peytremann-Bridevaux mfl. ...
... 2008, Kennedy mfl. 2007, tilbud for personer med diabetes type 2 (Sturt 2008, Wattana mfl. 2007), kols (Peytremann-Bridevaux mfl. ...
... A randomised controlled trial evaluating the addition of a structured education manual for general practice nurses in a high income context (the UK) found no differences in HbA1c between enhanced care (ACM) and current practice (TTR-only) arms. 19 However, this trial's ACM package was more than just the provision of education materials for healthcare providers, and health services context was also different since Pakistan is a low income setting. In the United Arab Emirates, a standard package of care that included education of healthcare professionals and patients, support for diabetes care, and improved recording of clinical information 20 showed improvements in some but not all processes of quality care, as in the present trial. ...
Background
There were an estimated 7 million people living with diabetes in Pakistan in 2014, and this is predicted to reach 11.4 million by 2030.
Aim
To assess if an integrated care package can achieve better control of diabetes.
Design & setting
The pragmatic cluster randomised controlled trial (cRCT) was conducted from December 2014–June 2016 at 14 primary healthcare facilities in Sargodha district. Opportunistic screening, diagnostic testing, and patient recording processes were introduced in both the control 'testing, treating, and recording' (TTR) arm, and the intervention 'additional case management' (ACM) arm, which also included a clinical care guide and pictorial flipbook for lifestyle education, associated clinician training, and mobile phone follow-up.
Method
Clinics were randomised on a 1:1 basis (sealed envelope lottery method) and 250 patients recruited in the ACM arm and 245 in the TTR-only arm (age ≥25 years and HbA1c >7%). The primary outcome was mean change in HbA1c (%) from baseline to 9-month follow-up. Patients and staff were not blinded.
Results
The primary outcome was available for n = 238/250 (95.2%) participants in the ACM arm and n = 219/245 (89.4%) participants in the TTR-only arm (all clusters). Cluster level mean outcome was -2.26 pp (95% confidence intervals [CI] = -2.99 to -1.53) for the ACM arm, and -1.44 pp (95% CI = -2.34 to -0.54) for the TTR-only arm. Cluster level mean ACM–TTR difference (covariate-unadjusted) was -0.82 pp (95% CI = -1.86 to 0.21; P = 0.11).
Conclusion
The ACM intervention in public healthcare facilities did not show a statistically significant effect on HbA1c reduction compared to the control (TTR-only) arm. Future evaluation should assess changes after a longer follow-up period, and minimal care enhancement in the comparator (control) arm.
... Sturt et al. used the DMSES as an outcome measure in a cluster randomized trial comparing the efficacy of the Diabetes Manual versus a 6-month delayed intervention. At 26 weeks, the total DMSES score was 11.2 point higher in the intervention group compared with the control group, denoting significantly higher confidence in self-care (Sturt et al., 2008). ...
This study aims to analyze the correlations and relevance of self-efficacy items in 411 patients with diabetes using network analysis. We found that the self-efficacy items structure is consistent between genders and types of diabetes. However, the strength of item correlations was significantly higher in type 2 diabetes. The items central to the network were following a regular diet in type 2 diabetes and adjusting diet when ill in type 1 diabetes. No significant gender differences were found. Knowledge of the most central aspects of self-efficacy and their interconnections can help clinicians to target psychoeducational interventions aimed at empowering patients.
... A wide variety of educational, self-management, and structured care interventions with the aim to improve HRQoL in diabetic populations exists [16][17][18][36][37][38][39][40][41][42][43][44][45]. Still, high quality randomized controlled trials are rare and little is known on the impact of DMPs on HRQoL [46]. ...
Background
Type 2 diabetes is a chronic disease associated with poorer health outcomes and decreased health related quality of life (HRQoL). The aim of this analysis was to explore the impact of a disease management programme (DMP) in type 2 diabetes on HRQoL. A multilevel model was used to explain the variation in EQ-VAS.
Methods
A cluster-randomized controlled trial—analysis of the secondary endpoint HRQoL. Our study population were general practitioners and patients in the province of Salzburg. The DMP “Therapie-Aktiv” was implemented in the intervention group, and controls received usual care. Outcome measure was a change in EQ-VAS after 12 months. For comparison of rates, we used Fisher’s Exact test; for continuous variables the independent T test or Welch test were used. In the multilevel modeling, we examined various models, continuously adding variables to explain the variation in the dependent variable, starting with an empty model, including only the random intercept. We analysed random effects parameters in order to disentangle variation of the final EQ-VAS.
Results
The EQ-VAS significantly increased within the intervention group (mean difference 2.19, p = 0.005). There was no significant difference in EQ-VAS between groups (mean difference 1.00, p = 0.339). In the intervention group the improvement was more distinct in women (2.46, p = 0.036) compared to men (1.92, p = 0.063). In multilevel modeling, sex, age, family and work circumstances, any macrovascular diabetic complication, duration of diabetes, baseline body mass index and baseline EQ-VAS significantly influence final EQ-VAS, while DMP does not. The final model explains 28.9% (EQ-VAS) of the total variance. Most of the unexplained variance was found on patient-level (95%) and less on GP-level (5%).
Conclusion
DMP “Therapie-Aktiv” has no significant impact on final EQ-VAS. The impact of DMPs in type 2 diabetes on HRQoL is still unclear and future programmes should focus on patient specific needs and predictors in order to improve HRQoL.
Trial registration Current Controlled trials Ltd., ISRCTN27414162
Electronic supplementary material
The online version of this article (10.1186/s13098-018-0330-9) contains supplementary material, which is available to authorized users.
... Additionally, SME strategies that incorporate individual goal setting (16), collaboration, problem solving (18), patient empowerment strategies (12) and tailored education (1) were effective in improving glycemic control and self-care outcomes for individuals with diabetes. Furthermore, SME results in positive changes in diabetes-related knowledge (19), as well as psychological (20)(21)(22)(23) and behavioural (20,24) domains. Basic knowledge and skills for SME include monitoring of relevant health parameters, healthy eating, physical activity, pharmacotherapy, prevention and management of hypo-and hyperglycemia, and prevention and surveillance of complications. ...
... Sturt et al. reported that an individualized approach with the help of a diabetes guide and telephonic support has demonstrated clinically significant reductions in A1c levels, for T2DM patients with poor glycemic control. [17] Health literacy has been reported as a significant factor influencing the patients' glycemic control. [18] Clinical outcome can be achieved by addressing patients' literacy. ...
Background:
Diabetes self-care activities, like, healthy diet, regular exercise, self-monitoring of blood glucose, and rational use of medicines are considered to play a vital role in establishing euglycemia. Health literacy among type 2 diabetes mellitus (T2DM) patients in Pakistan is very low, which is the most likely cause for poor clinical outcomes. This study is designed to investigate the impact of pharmacist-led educational intervention on glycemic control, self-care activities and disease knowledge among T2DM patients in Pakistan.
Methods:
In this randomized controlled trail, effectiveness of a 6-month pharmacist-led educational intervention will be examined on glycemic control, diabetes self-care activities and disease knowledge of 80 adult T2DM patients (age >30 years) with poorly controlled T2DM (HbA1c> 7%), after randomizing them into intervention and control groups, at diabetes care clinic of Capital Hospital Islamabad, Pakistan.
Results:
The primary outcome is change in patients' HbA1c, whereas, changes in self-care activities and patients' disease knowledge are the secondary outcomes. After baseline assessment of their self-care activities and disease knowledge by using validated Urdu versions of Diabetes Self-management Questionnaire (DSMQ) and Diabetes Knowledge Questionnaire (DKQ), respectively, interventional group patients will be supplemented with a face-to-face pharmacist-led educational intervention, whereas, the control group will receive usual care. Intervention arm patients will be educated successively at their first follow-up visit (12th week) and telephonically after every 4 weeks. All assessments will be made at baseline and end of trail for both intervention and control groups. Multivariate general linear model will be applied to analyze the effects of the intervention.
Conclusion:
Glycemic control in T2DM patients requires optimum self-care activities. This study is an attempt to improve self-care behaviors among poorly controlled T2DM patients who are at higher risk of diabetes-associated late complications.
... Such programs would affect the patients' behaviors not only through education but also by improving their perception of their disease and increasing their motivation toward self-care. Then, self-management gradually would substitute for the absolute obedience to the physi-cians' orders (5). ...
Background: Type 2 diabetes is a chronic disease that is spreading very quickly worldwide and is second in priority for investigation of chronic diseases. According to research, self-efficacy is low in diabetic patients. Objectives: This study analyzes the effect of empowerment programs on self-efficacy in type 2 diabetes patients. Patients and Methods: In this clinical trial, 100 patients with type 2 diabetes who had inclusion criteria were chosen randomly and divided into control and experimental groups by a randomized block method. Intervention was accomplished through educational sessions scheduled twice a week for four weeks. Diabetes self-efficacy questionnaires were completed before and two months after the intervention for each group. Data were analyzed using the SPSS 16 and the Mann Whitney U, chi-square, exact Fisher’s, and t-test statistical tests. Results: Before intervention, the mean score of self-efficacy was 45±14.49and39.61±17.01 for the experimental and control groups, respectively, and the difference was not significant (P = 0.1). Two months after the intervention, the mean of self-efficacy was 55.71± 13.25 and 40.24±17.55 for experimental and control groups, respectively; and the difference was significant (P < 0.001). Conclusions: Using an empowerment program had positive effects on self-efficacy in patients with type 2 diabetes.
... 39 The generally poor uptake of group-based programs for the management of T2DM may have also contributed to the reduced recruitment. 30,[40][41][42] A recent study found that the three main reasons for non-attendance of group programs, as reported by T2DM patients, were the lack of information or perceived benefit of the programs, unmet personal preferences such as poor timing or accessibility of group locations and the shame and stigma of diabetes. 43 Practitioners should consider how health professionals in primary care communicate with their T2DM patients with regards to group education programs, the optimal timing and location of group programs and focus on recruitment methods that minimise any health-related stigma around T2DM. 43 The evaluation found modest improvements in body weight, BMI and waist circumference as well as the QOL domains, nutrition knowledge, diabetes knowledge and self-efficacy measures. ...
Aim:
The present study developed and evaluated a patient-centred, patient-directed, group-based education program for the management of type 2 diabetes mellitus.
Methods:
Two frameworks, the Medical Research Council (MRC) framework for developing and evaluating complex interventions and the RE-AIM framework were followed. Data to develop the intervention were sourced from scoping of the literature and formative evaluation. Program evaluation comprised analysis of primary recruitment of participants through general practitioners, baseline and end-point measures of anthropometry, four validated questionnaires, contemporaneous facilitator notes and telephone interviews with participants.
Results:
A total of 16 participants enrolled in the intervention. Post-intervention results were obtained from 13 participants, with an estimated mean change from baseline in weight of -0.72 kg (95%CI -1.44 to -0.01), body mass index of -0.25 kg/m(2) (95%CI -0.49 to -0.01) and waist circumference of -1.04 cm (95%CI -4.52 to 2.44). The group education program was acceptable to participants. The results suggest that recruitment through general practitioners is ineffective, and alternative recruitment strategies are required.
Conclusions:
This patient-centred, patient-directed, group-based intervention for the management of type 2 diabetes mellitus was both feasible and acceptable to patients. Health professionals should consider the combined use of the MRC and RE-AIM frameworks in the development of interventions to ensure a rigorous design process and to enable the evaluation of all phases of the intervention, which will facilitate translation to other settings. Further research with a larger sample trialling additional recruitment strategies, evaluating further measures of effectiveness and utilising lengthier follow-up periods is required.
... There is emerging evidence of the rate of elevated DD in study samples. In UK primary care, 21% of adults report elevated DD. 15 In the Netherlands, 4% and 19% of primary and secondary care patients, respectively, experience elevated DD. 16 In Australia, elevated DD affects 28%, 22% and 17% of adults with Type 1 and Type 2 diabetes, using and not using insulin, respectively. 17 The USA community point prevalence of elevated DD is 18%, which increases to 48% over an 18 months period. ...
Diabetes distress has implications for diabetes end-points, hence targeted interventions are indicated; yet, preliminary work quantifying and characterising the problem is required. We sought to identify the potential magnitude and determinants of elevated diabetes distress across study populations. Databases such as Medline, PsycINFO and Embase were searched for studies (n ≥50) administering the problem areas in Diabetes scale or Diabetes Distress scale, in adults with Type 1 or 2 diabetes. Random effects meta-analysis and meta-regression estimated the average rate of elevated diabetes distress and prognostic contribution of age, gender, HbA1c, and health-care context. Of the 16,627 citations identified, adequate data were available for 58 studies. On average, 22% of participants reported elevated diabetes distress. Only female gender and secondary care predicted a higher rate of elevated diabetes distress. A quarter of people with diabetes have a level of distress likely to impact outcomes. Secondary-care practitioners should be vigilant of women with diabetes.
... This might be explained in relation to improvements in diabetes management self-efficacy as there are several included studies that identify reductions in DD alongside improvements in selfefficacy. [37][38][39][40] People develop mastery in relation to their diabetes management through knowledge and skill acquisition derived from the diabetes content alongside communication, reflection and motivational insights derived from the psychological components. This may enable them to experience a level of control that reduces their sense of helplessness in relation to this complex condition. ...
Aims: To identify randomised controlled trials (RCTs) in which diabetes distress (DD) was assessed in adults under experimental conditions and to undertake meta-analysis of intervention components to determine effective interventions for reducing DD.Methods: Systematic review searching Medline, Psychinfo and Embase to March 2013 for studies measuring DD. Two reviewers assessed citations and full papers for eligibility based on RCT design and Problem Areas in Diabetes Scale or Diabetes Distress Scale outcome measure. Interventions were categorised by content and medium of delivery. Meta-analyses were undertaken by intervention category where ≥7 studies were available. Standardised mean differences and 95% confidence intervals were computed and combined in a random effects meta-analysis.Results: Of 16 627 citations reviewed, 41 RCTs involving 6650 participants were included. Twenty-one a priori meta-analyses were undertaken. Effective interventions were psycho-education (−0.21 [−0.33, −0.09]), gener...
Bericht zuhanden des Bundesamts für Gesundheit (BAG)
Aims
To undertake a qualitative study of a multimodal behavioural intervention and research protocol developed to improve wellness in women with type 2 diabetes mellitus (T2DM), the Women’s Wellness with Type 2 Diabetes program (WWDP).
Methods
Semi-structured interviews were conducted with 15 participants who completed the WWDP. The interviews were transcribed verbatim and analysed thematically in an iterative process.
Results
Themes developing from interviews were broadly grouped into three domains, 1) Hope for a better everyday life; 2) Reflection of the program and its contents; and 3) Impacts on health and wellbeing. Participants viewed the WWDP as a necessary and valuable approach that was crucial in helping them adopt strategies to improve their wellbeing and prevent complications associated with T2DM. Some participants expressed ambivalence towards their adherence to the program due to day-to-day life commitments. The most appreciated feature of the program were the individualised approach adopted by the consultation nurse via skype, convenient appointments, the provision of credible and factual information and the accessible website.
Conclusions
This study critically evaluated perceptions of participants towards the WWDP and provided important recommendations for improving the delivery and sustainability of the program in future. Participants perceived the program as an effective means of supporting their T2DM self-management and improving wellbeing.
Aims
The current study aimed to examine feasibility of participant recruitment and retention rates for the Women’s Wellness with Type 2 Diabetes program (WWDP), and to assess initial efficacy of the program in improving wellbeing outcomes.
Methods
70 midlife women with type 2 diabetes mellitus (T2DM) participated in a 12-week wellness-focused intervention, the WWDP. The WWDP involved a structured book (with participatory activities), an interactive website and nurse consultations. This study had an Australian and a UK arm. Analyses were conducted using chi-square, McNemar, paired t-test, and Wilcoxon signed-ranks tests.
Results
The attrition rate for the sample was 22.2%. Overall, significant improvement was observed in diabetes distress (DD), diabetes self-efficacy, weight, BMI, menopausal symptoms and sleep symptoms from baseline to program completion at 12 weeks. Australian participants were also more likely to meet fruit recommendation guidelines and had significant waist- and hip-circumference reductions.
Conclusions
Good retention rates and initial efficacy findings indicated feasibility of the WWDP as a promising 12-week health and wellness program for women with T2DM. They also suggest incorporating a focus on self-efficacy and gendered information may be important in improving wellness and health outcomes related to distress and menopause.
Introduction
People with diabetes are often associated with multifaceted factors and comorbidities. Diabetes management frameworks need to integrate a biopsychosocial, patient-centred approach. Despite increasing efforts in promotion and diabetes education, interventions integrating both physical and mental health components are still lacking in Malaysia. The Optimal Health Programme (OHP) offers an innovative biopsychosocial framework to promote overall well-being and self-efficacy, going beyond education alone and has been identified as relevant within the primary care system. Following a comprehensive cultural adaptation process, Malaysia’s first OHP was developed under the name ‘Pohon Sihat’ (OHP). The study aims to evaluate the effectiveness of the mental health-based self-management and wellness programme in improving self-efficacy and well-being in primary care patients with diabetes mellitus.
Methods and analysis
This biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed.
Ethics and dissemination
This study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal.
Trial registration number
NCT03601884 .
Background:
Primary health professionals are well positioned to support the delivery of patient self-management in an evidence-based, structured capacity. A need exists to better understand the active components required for effective self-management support, how these might be delivered within primary care, and the training and system changes that would subsequently be needed.
Objectives:
(1) To examine self-management support interventions in primary care on health outcomes for a wide range of diseases compared to usual standard of care; and (2) To identify the effective strategies that facilitate positive clinical and humanistic outcomes in this setting.
Method:
A systematic review of randomized controlled trials evaluating self-management support interventions was conducted following the Cochrane handbook & PRISMA guidelines. Published literature was systematically searched from inception to June 2019 in PubMed, Scopus and Web of Science. Eligible studies assessed the effectiveness of individualized interventions with follow-up, delivered face-to-face to adult patients with any condition in primary care, compared with usual standard of care. Matrices were developed that mapped the evidence and components for each intervention. The methodological quality of included studies were appraised.
Results:
6,510 records were retrieved. 58 studies were included in the final qualitative synthesis. Findings reveal a structured patient-provider exchange is required in primary care (including a one-on-one patient-provider consultation, ongoing follow up and provision of self-help materials). Interventions should be tailored to patient needs and may include combinations of strategies to improve a patient's disease or treatment knowledge; independent monitoring of symptoms, encouraging self-treatment through a personalized action plan in response worsening symptoms or exacerbations, psychological coping and stress management strategies, and enhancing responsibility in medication adherence and lifestyle choices. Follow-up may include tailored feedback, monitoring of progress with respect to patient set healthcare goals, or honing problem-solving and decision-making skills. Theoretical models provided a strong base for effective SMS interventions. Positive outcomes for effective SMS included improvements in clinical indicators, health-related quality of life, self-efficacy (confidence to self-manage), disease knowledge or control. An SMS model has been developed which sets the foundation for the design and evaluation of practical strategies for the construct of self-management support interventions in primary healthcare practice.
Conclusions:
These findings provide primary care professionals with evidence-based strategies and structure to deliver SMS in practice. For this collaborative partnership approach to be more widely applied, future research should build on these findings for optimal SMS service design and upskilling healthcare providers to effectively support patients in this collaborative process.
This PhD thesis compiles the following studies:
1. To examine the prevalence of DD and depression, and their associated factors in
Malaysian adult T2DM patients.
2. To examine whether DD in Malaysian patients is associated with self-efficacy,
self-care activity, medication adherence and disease control.
3. To examine which factors are related to change in DD or depressive symptoms
after 3 years of follow-up in Malaysian adults with T2DM who received regular
primary diabetes care.
4. To conduct a systematic review on the effects of psychological interventions on
DD in adults with T2DM
5. To design and develop a brief value-based emotion-focused educational
programme for adults with T2DM to reduce diabetes-related distress
6. To translate and validate a Malay version of the Brief Illness Perception
Questionnaire
7. To evaluate the effectiveness of a brief value-based emotion-focused educational
programme in adults with T2DM on DD
Background
In the UK, 6% of the UK population have diabetes mellitus, 90% of whom have type 2 diabetes mellitus (T2DM). Diabetes mellitus accounts for 10% of NHS expenditure (£14B annually). Good self-management may improve health outcomes. NHS policy is to refer all people with T2DM to structured education, on diagnosis, to improve their self-management skills, with annual reinforcement thereafter. However, uptake remains low (5.6% in 2014–15). Almost all structured education is group based, which may not suit people who work, who have family or other caring commitments or who simply do not like group-based formats. Moreover, patient needs vary with time and a single education session at diagnosis is unlikely to meet these evolving needs. A web-based programme may increase uptake.
Objectives
Our aim was to develop, evaluate and implement a web-based self-management programme for people with T2DM at any stage of their illness journey, with the goal of improving access to, and uptake of, self-management support, thereby improving health outcomes in a cost-effective manner. Specific objectives were to (1) develop an evidence-based theoretically informed programme that was acceptable to patients and health-care professionals (HCPs) and that could be readily implemented within routine NHS care, (2) determine the clinical effectiveness and cost-effectiveness of the programme compared with usual care and (3) determine how best to integrate the programme into routine care.
Design
There were five linked work packages (WPs). WP A determined patient requirements and WP B determined HCP requirements for the self-management programme. WP C developed and user-tested the Healthy Living for People with type 2 Diabetes (HeLP-Diabetes) programme. WP D was an individually randomised controlled trial in primary care with a health economic analysis. WP E used a mixed-methods and case-study design to study the potential for implementing the HeLP-Diabetes programme within routine NHS practice.
Setting
English primary care.
Participants
People with T2DM (WPs A, D and E) or HCPs caring for people with T2DM (WPs B, C and E).
Intervention
The HeLP-Diabetes programme; an evidence-based theoretically informed web-based self-management programme for people with T2DM at all stages of their illness journey, developed using participatory design principles.
Main outcome measures
WPs A and B provided data on user ‘wants and needs’, including factors that would improve the uptake and accessibility of the HeLP-Diabetes programme. The outcome for WP C was the HeLP-Diabetes programme itself. The trial (WP D) had two outcomes measures: glycated haemoglobin (HbA 1c ) level and diabetes mellitus-related distress, as measured with the Problem Areas in Diabetes (PAID) scale. The implementation outcomes (WP E) were the adoption and uptake at clinical commissioning group, general practice and patient levels and the identification of key barriers and facilitators.
Results
Data from WPs A and B supported our holistic approach and addressed all areas of self-management (medical, emotional and role management). HCPs voiced concerns about linkage with the electronic medical records (EMRs) and supporting patients to use the programme. The HeLP-Diabetes programme was developed and user-tested in WP C. The trial (WP D) recruited to target ( n = 374), achieved follow-up rates of over 80% and the intention-to-treat analysis showed that there was an additional improvement in HbA 1c levels at 12 months in the intervention group [mean difference –0.24%, 95% confidence interval (CI) –0.44% to –0.049%]. There was no difference in overall PAID score levels (mean difference –1.5 points, 95% CI –3.9 to 0.9 points). The within-trial health economic analysis found that incremental costs were lower in the intervention group than in the control group (mean difference –£111, 95% CI –£384 to £136) and the quality-adjusted life-years (QALYs) were higher (mean difference 0.02 QALYs, 95% CI 0.000 to 0.044 QALYs), meaning that the HeLP-Diabetes programme group dominated the control group. In WP E, we found that the HeLP-Diabetes programme could be successfully implemented in primary care. General practices that supported people in registering for the HeLP-Diabetes programme had better uptake and registered patients from a wider demographic than those relying on patient self-registration. Some HCPs were reluctant to do this, as they did not see it as part of their professional role.
Limitations
We were unable to link the HeLP-Diabetes programme with the EMRs or to determine the effects of the HeLP-Diabetes programme on users in the implementation study.
Conclusions
The HeLP-Diabetes programme is an effective self-management support programme that is implementable in primary care.
Future work
The HeLP-Diabetes research team will explore the following in future work: research to determine how to improve patient uptake of self-management support; develop and evaluate a structured digital educational pathway for newly diagnosed people; develop and evaluate a digital T2DM prevention programme; and the national implementation of the HeLP-Diabetes programme.
Trial registration
Research Ethics Committee reference number 10/H0722/86 for WPs A–C; Research Ethics Committee reference number 12/LO/1571 and UK Clinical Research Network/National Institute for Health Research (NIHR) Portfolio 13563 for WP D; and Research Ethics Committee 13/EM/0033 for WP E. In addition, for WP D, the study was registered with the International Standard Randomised Controlled Trial Register as reference number ISRCTN02123133.
Funding details
This project was funded by the NIHR Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research ; Vol. 6, No. 5. See the NIHR Journals Library website for further project information.
Evidence for the use of structured education in diabetes management is accumulating and has shown positive influence in the management of Type-2 diabetes.
Objective:
To assess the impact of structured education on glucose control and hypoglycaemia in the management of Type-2 diabetes.
Methods:
A systematic review was done using Medline via Ovid and EMBASE databases of published English literature between 1980 and 2014. Included studies were randomized control trials that assessed the impact of structured education on glucose control and hypoglycaemia.
Results:
Out of the 12,086 full text articles were identified, 36 full text articles were finally considered for this review after applying both inclusion and exclusion criteria, of which 34 were exclusively on the effect of structured diabetes education on glucose control whilst 2 were studies on the effects of structured diabetes education on glucose control and hypoglycaemia. Majority of the studies included a predominant Caucasian population. There was heterogeneity in the included studies such as intervention methods and intensity as well as follow up periods. Group based education was preferred over individual education by most studies. Overall, most of the studies showed a significant positive effect on glycaemic control compared with control groups. One study showed a significant impact of structured education on hypoglycaemia.
Conclusion:
Structured education has positive impact on glucose control and hypoglycaemia in Type-2 diabetes and must be incorporated in routine care.
Funding:
The study was funded by the authors.
Both type 1 and type 2 diabetes are associated with long-term complications that can be prevented or delayed by intensive glycaemic management. People who are empowered and skilled to self-manage their diabetes have improved health outcomes. Over the past 20 years, diabetes self-management education programmes have been shown to be efficacious and cost-effective in promotion and facilitation of self-management, with improvements in patients' knowledge, skills, and motivation leading to improved biomedical, behavioural, and psychosocial outcomes. Diabetes self-management education programmes, developed robustly with an evidence-based structured curriculum, vary in their method of delivery, content, and use of technology, person-centred philosophy, and specific aims. They are delivered by trained educators, and monitored for quality by independent assessors and routine audit. Self-management education should be tailored to specific populations, taking into consideration the type of diabetes, and ethnic, social, cognitive, literacy, and cultural factors. Ways to improve access to and uptake of diabetes self-management programmes are needed globally.
Background:
Many adults with type 2 diabetes mellitus (T2DM) experience a psychosocial burden and mental health problems associated with the disease. Diabetes-related distress (DRD) has distinct effects on self-care behaviours and disease control. Improving DRD in adults with T2DM could enhance psychological well-being, health-related quality of life, self-care abilities and disease control, also reducing depressive symptoms.
Objectives:
To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM.
Search methods:
We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases.
Selection criteria:
We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials if they compared different psychological interventions or compared a psychological intervention with usual care. Primary outcomes were DRD, health-related quality of life (HRQoL) and adverse events. Secondary outcomes were self-efficacy, glycosylated haemoglobin A1c (HbA1c), blood pressure, diabetes-related complications, all-cause mortality and socioeconomic effects.
Data collection and analysis:
Two review authors independently identified publications for inclusion and extracted data. We classified interventions according to their focus on emotion, cognition or emotion-cognition. We performed random-effects meta-analyses to compute overall estimates.
Main results:
We identified 30 RCTs with 9177 participants. Sixteen trials were parallel two-arm RCTs, and seven were three-arm parallel trials. There were also seven cluster-randomised trials: two had four arms, and the remaining five had two arms. The median duration of the intervention was six months (range 1 week to 24 months), and the median follow-up period was 12 months (range 0 to 12 months). The trials included a wide spectrum of interventions and were both individual- and group-based.A meta-analysis of all psychological interventions combined versus usual care showed no firm effect on DRD (standardised mean difference (SMD) -0.07; 95% CI -0.16 to 0.03; P = 0.17; 3315 participants; 12 trials; low-quality evidence), HRQoL (SMD 0.01; 95% CI -0.09 to 0.11; P = 0.87; 1932 participants; 5 trials; low-quality evidence), all-cause mortality (11 per 1000 versus 11 per 1000; risk ratio (RR) 1.01; 95% CI 0.17 to 6.03; P = 0.99; 1376 participants; 3 trials; low-quality evidence) or adverse events (17 per 1000 versus 41 per 1000; RR 2.40; 95% CI 0.78 to 7.39; P = 0.13; 438 participants; 3 trials; low-quality evidence). We saw small beneficial effects on self-efficacy and HbA1c at medium-term follow-up (6 to 12 months): on self-efficacy the SMD was 0.15 (95% CI 0.00 to 0.30; P = 0.05; 2675 participants; 6 trials; low-quality evidence) in favour of psychological interventions; on HbA1c there was a mean difference (MD) of -0.14% (95% CI -0.27 to 0.00; P = 0.05; 3165 participants; 11 trials; low-quality evidence) in favour of psychological interventions. Our included trials did not report diabetes-related complications or socioeconomic effects.Many trials were small and were at high risk of bias for incomplete outcome data as well as possible performance and detection biases in the subjective questionnaire-based outcomes assessment, and some appeared to be at risk of selective reporting. There are four trials awaiting further classification. These are parallel RCTs with cognition-focused and emotion-cognition focused interventions. There are another 18 ongoing trials, likely focusing on emotion-cognition or cognition, assessing interventions such as diabetes self-management support, telephone-based cognitive behavioural therapy, stress management and a web application for problem solving in diabetes management. Most of these trials have a community setting and are based in the USA.
Authors' conclusions:
Low-quality evidence showed that none of the psychological interventions would improve DRD more than usual care. Low-quality evidence is available for improved self-efficacy and HbA1c after psychological interventions. This means that we are uncertain about the effects of psychological interventions on these outcomes. However, psychological interventions probably have no substantial adverse events compared to usual care. More high-quality research with emotion-focused programmes, in non-US and non-European settings and in low- and middle-income countries, is needed.
Data collection and managementAnalysis – an introductionAnalyses for two-arm, completely randomised, stratified or minimised designsAnalyses for other designsIntention to treat and missing valuesAnalysis planningSummaryReferences
Lack of effectiveness of interventions evaluated in cluster randomised trialsWhat is a complex intervention?Phases in the development of a complex interventionIdentifying evidence for potential intervention effect (pre-clinical phase)Understanding more about intervention components (modelling phase)Developing the optimum intervention and study design (exploratory trial phase)What is the intervention?SummaryReferences
Parallel designs with only two armsCohort versus cross-sectional designsParallel designs with more than two armsCrossover designsFurther design considerationsSummaryReferences
What is the ICC?Sources of ICC estimatesChoosing the ICC for use in sample size calculationsCalculating ICC valuesUncertainty in ICCsSummaryReferences
Trial quality and reporting qualitySteps to improve trial reporting in the early stages of the trialReporting randomised trials in journal and conference abstractsApplication of CONSORT statement to cluster randomised trialsSummaryReferences
Group-based education has the potential to substantially improve the outcomes of individuals with type 2 diabetes mellitus (T2DM) and reduce the enormous burden that chronic diseases place on healthcare systems worldwide. Despite this proven effectiveness, the utilisation of group services for the management of T2DM by Australian dietitians is surprisingly low. This study surveyed a sample of 263 Australian dietitians to explore the utilisation of group-based education for T2DM, as well as dietitians' preferences for practice and training. The results of this study indicate that Australian dietitians are currently under-utilising group-based education programs for the management of T2DM, with the primary reasons identified as a lack of training provided to dietitians in the area, limited access to facilities suitable for conducting group education, the perceived poor cost-effectiveness of these programs, and the lack of evidence-based practice guidelines for the group-based management of persons with T2DM. Additionally, the majority of preferences for further training were for either face-to-face or web-based formal training conducted over 3-6h. Clear, evidence-based practice guidelines and training resources for group education for the management of T2DM are needed in order to encourage better utilisation of group-based education by Australian dietitians.
We undertook a pilot service-evaluation of prescribed internet-based patient education films for patients with type 2 diabetes. The uptake was 28% and film watching was associated with a relative mean difference in HbA1c of −9.0 mmol/mol in the film watchers compared to non-watchers over a three-month period (P = 0.0008).
A growing number of instruments measuring diabetes-specific health-related quality of life (HRQOL) have been identified in previous systematic reviews, the most recent being published in 2008. The purpose of this paper is report on an updated systematic review of diabetes-specific HRQOL measures highlighting the time period 2006-2016; to deconstruct existing diabetes-specific HRQOL measures into a simple framework for evaluating the goodness-of-fit between specific research needs and instrument characteristics; and to present core characteristics of measures not yet reported in other reviews to further facilitate scale selection. Using the databases Medline, Pubmed, CINAHL, OVID Embase, and PsycINFO, we identified 20 diabetes-specific HRQOL measures that met our inclusion criteria. For each measure, we extracted eight core characteristics for our measurement selection framework. These characteristics include target population (type 1 vs. type 2), number and type of HRQOL dimensions measured and scored, type of score and calculation algorithm, sensitivity to change data reported in subsequent studies, number of survey items, approximate time length to complete, number of studies using the instrument in the past 10 years, and specific languages instruments is translated. This report provides a way to compare and contrast existing diabetes-specific HRQOL measures to aid in appropriate scale selection and utilization.
People with type 2 diabetes should have access to quality structured education to successfully self-manage their condition. Education interventions that are adopted should demonstrate their quality by meeting national standards and criteria, and be supported by evidence from gold standard randomised controlled trials to demonstrate efficacy and effectiveness, including costeffectiveness. Currently, the provision of structured education in primary care is variable. Mostly provision remains ad hoc, is vulnerable to the tough prevailing economic climate, and has become a postcode lottery. Good evidence now exists for the benefits of structured education, through national programmes that can be adopted by primary healthcare. This article reviews the evidence from four key diabetes structured education programmes.
http://edepot.wur.nl/318483
Presents an integrative theoretical framework to explain and to predict psychological changes achieved by different modes of treatment. This theory states that psychological procedures, whatever their form, alter the level and strength of self-efficacy. It is hypothesized that expectations of personal efficacy determine whether coping behavior will be initiated, how much effort will be expended, and how long it will be sustained in the face of obstacles and aversive experiences. Persistence in activities that are subjectively threatening but in fact relatively safe produces, through experiences of mastery, further enhancement of self-efficacy and corresponding reductions in defensive behavior. In the proposed model, expectations of personal efficacy are derived from 4 principal sources of information: performance accomplishments, vicarious experience, verbal persuasion, and physiological states. Factors influencing the cognitive processing of efficacy information arise from enactive, vicarious, exhortative, and emotive sources. The differential power of diverse therapeutic procedures is analyzed in terms of the postulated cognitive mechanism of operation. Findings are reported from microanalyses of enactive, vicarious, and emotive modes of treatment that support the hypothesized relationship between perceived self-efficacy and behavioral changes. (21/2 p ref)
The National Institute for Clinical Excellence (NICE) guideline for diabetes patient education offers little to inform National Health Services (NHS) Trusts in the curriculum design of self-management education programmes. The study aim was to conduct a patient-needs assessment of the educational curriculum content and support needs for Type 2 diabetes self-management. Different stages of the condition were chosen to identify whether needs remained constant or changed with time and experience. Six focus groups were convened for people who had recently received a new diagnosis or changed therapy. Twenty-three participants were recruited from primary care and the media in the UK. The educational curriculum support needs comprised: access to care and support, continuity of health care professional, lay support, high-quality care and support, and a positive cognitive appraisal of experiences. Needs were broadly similar irrespective of the new change situation. The current emphasis on lay support concurs with a proportion of the needs of our study participants. Motivational communications with patients need to be prioritized to enable patients to address therapeutic goals.
Assessing fidelity of behavioural interventions is important, but demanding and rarely done. This study assessed adherence to behaviour change techniques used in an intervention to increase physical activity among sedentary adults (ProActive; N = 365). Transcripts of 108 sessions with a sub-sample of 27 participants were assessed. An independent assessor coded adherence of four 'facilitators' who delivered the intervention to 208 protocol-specified facilitator behaviours (e.g. 'elicit perceived advantages of becoming more active') in four key sessions. Four raters classified the 208 behaviours under 14 techniques (e.g., goal setting, use of rewards) to enable calculation of adherence to techniques. Observed adherence to techniques across participants was modest (median 44%, IQR 35-62%), and lower than that reported by facilitators. Adherence differed between facilitators (range: 26-63%) and decreased across the four sessions (mean drop 9% per session, 95% confidence interval 7-11%). In this small sample facilitator adherence was unrelated to (change in) participants' physical activity or its cognitive predictors: Attitudes, subjective norm, perceived behavioural control and intention. Future research should investigate causal pathways between fidelity indicators and outcomes in larger samples and develop and test less intensive measures of fidelity.
To describe a new measure of psychosocial adjustment specific to diabetes, the Problem Areas in Diabetes Survey (PAID), and to present initial information on its reliability and validity.
Before their routine clinic appointments, 451 female patients with type I and type II diabetes, all of whom required insulin, completed a self-report survey. Included in the survey was the PAID, a 20-item questionnaire in which each item represents a unique area of diabetes-related psychosocial distress. Each item is rated on a six-point Likert scale, reflecting the degree to which the item is perceived as currently problematic. A total scale score, hypothesized to reflect the overall level of diabetes-related emotional distress, is computed by summing the total item responses. To examine the concurrent validity of the PAID, the survey also included a series of standardized questionnaires assessing psychosocial functioning (general emotional distress, fear of hypoglycemia, and disordered eating), attitudes toward diabetes, and self-care behaviors. All subjects were assessed for HbA1, within 30 days of survey completion and again approximately 1-2 years later. Finally, long-term diabetic complications were determined through chart review.
Internal reliability of the PAID was high, with good item-to-total correlations. Approximately 60% of the subject sample reported at least one serious diabetes-related concern. As expected, the PAID was positively associated with relevant psychosocial measures of distress, including general emotional distress, disordered eating, and fear of hypoglycemia, short- and long-term diabetic complications, and HbA1, and negatively associated with reported self-care behaviors. The PAID accounted for approximately 9% of the variance in HbA1. Diabetes-related emotional distress, as measured by the PAID, was found to be a unique contributor to adherence to self-care behaviors after adjustment for age, diabetes duration, and general emotional distress. In addition, the PAID was associated with HbA1 even after adjustment for age, diabetes duration, general emotional distress, and adherence to self-care behaviors.
These findings suggest that the PAID, a brief, easy-to-administer instrument, may be valuable in assessing psychosocial adjustment to diabetes. In addition to high internal reliability, the consistent pattern of correlational findings indicates that the PAID is tapping into relevant aspects of emotional distress and that its particular feature, the measurement of diabetes-related emotional distress, is uniquely associated with diabetes-relevant outcomes. These data are also consistent with the hypothesis that diabetes-related emotional distress, separate from general emotional distress, is an independent and major contributor to poor adherence. Given that the study was limited to female patients using insulin, further examination of the clinical usefulness of the PAID will need to focus on more heterogeneous samples.
This article summarizes the development and validation of a scale to measure the level of self-efficacy of patients with type 2 diabetes mellitus. Self-efficacy is described as people's belief in their capability to organize and execute the course of action required to deal with prospective situations. This self-efficacy scale was developed based on the self-care activities these patients have to carry out in order to manage their diabetes. The following psychometric properties of this scale were established: content validity, construct validity, internal consistency and stability. The original scale contained 42 items. A panel of five experts in diabetes and four self-efficacy experts evaluated the original scale two times for relevance and clarity. This content validity procedure resulted in a final scale which consisted of 20 items. Subsequently, patients with type 2 diabetes were asked to complete this 20-item scale and further tests were done with the 94 usable responses. Factor analysis identified four factors, all of which were related to clusters of self-care activities used to manage diabetes which comprised this scale. The internal consistency of the total scale was alpha=0.81 and the test-retest reliability with a 5-week time interval was r=0.79 (P < 0.001).
To examine the cross-cultural validity of the Problem Areas in Diabetes Scale (PAID) in Dutch and U.S. diabetic patients.
A total of 1,472 Dutch people with diabetes completed the PAID along with other self-report measures of affect. Statistics covered Cronbach's alpha, exploratory factor analysis (EFA), and confirmatory factor analysis (CFA), Pearson's product-moment correlation, and t tests. Psychometric properties of PAID were compared for Dutch and U.S. diabetic patients.
Internal consistency of the Dutch PAID was high and stable across sex and type of diabetes. Test-retest reliability was high. Principal component analyses confirmed 1 general 20-item factor, whereas EFA identified 4 new subdimensions: negative emotions, treatment problems, food-related problems, and lack of social support. These dimensions were confirmed with CFA and were replicated in the U.S. sample. The PAID and its subscales demonstrated moderate to high associations in the expected direction with other measures of affect. Dutch and U.S. subjects reported having the same problem areas, with U.S. patients reporting higher emotional distress levels both in type 1 and type 2 diabetes.
The Dutch and U.S. 20-item PAID appeared to be psychometrically equivalent, which allowed for cross-cultural comparisons.
To systematically review the effectiveness of self-management training in type 2 diabetes.
MEDLINE, Educational Resources Information Center (ERIC), and Nursing and Allied Health databases were searched for English-language articles published between 1980 and 1999. Studies were original articles reporting the results of randomized controlled trials of the effectiveness of self-management training in people with type 2 diabetes. Relevant data on study design, population demographics, interventions, outcomes, methodological quality, and external validity were tabulated. Interventions were categorized based on educational focus (information, lifestyle behaviors, mechanical skills, and coping skills), and outcomes were classified as knowledge, attitudes, and self-care skills; lifestyle behaviors, psychological outcomes, and quality of life; glycemic control; cardiovascular disease risk factors; and economic measures and health service utilization.
A total of 72 studies described in 84 articles were identified for this review. Positive effects of self-management training on knowledge, frequency and accuracy of self-monitoring of blood glucose, self-reported dietary habits, and glycemic control were demonstrated in studies with short follow-up (<6 months). Effects of interventions on lipids, physical activity, weight, and blood pressure were variable. With longer follow-up, interventions that used regular reinforcement throughout follow-up were sometimes effective in improving glycemic control. Educational interventions that involved patient collaboration may be more effective than didactic interventions in improving glycemic control, weight, and lipid profiles. No studies demonstrated the effectiveness of self-management training on cardiovascular disease-related events or mortality; no economic analyses included indirect costs; few studies examined health-care utilization. Performance, selection, attrition, and detection bias were common in studies reviewed, and external generalizability was often limited.
Evidence supports the effectiveness of self-management training in type 2 diabetes, particularly in the short term. Further research is needed to assess the effectiveness of self-management interventions on sustained glycemic control, cardiovascular disease risk factors, and ultimately, microvascular and cardiovascular disease and quality of life.
The expert patient: a new approach to chronic disease management for the twenty-first century, produced by the Department of Health, recommends the introduction of 'user-led self management' for chronic diseases to all areas of the NHS by 2007. The premise is that many patients are expert in managing their disease, and this could be used to encourage others to become 'key decision makers in the treatment process'. Furthermore, these expert patients could 'contribute their skills and insights for the further improvement of services'. It is hypothesised that self-management programmes could reduce the severity of symptoms and improve confidence, resourcefulness and self-efficacy. It is stressed that this is more than just patient education to improve compliance. Instead there should be 'a cultural change...so that user-led self management can be fully valued and understood by healthcare professionals'. I point out that these ideas, while welcome, are not particularly new. Achieving the desired culture change will not be easy.
There is enough evidence that physical activity is an effective therapeutic tool in the management of type 2 diabetes. The present study was designed to validate a counseling strategy that could be used by physicians in their daily outpatient practice to promote the adoption and maintenance of physical activity by type 2 diabetic subjects.
The long-term (2-year) efficacy of the behavioral approach (n = 182) was compared with usual care treatment (n = 158) in two matched, randomized groups of patients with type 2 diabetes who had been referred to our Outpatient Diabetes Center. The outcome of the intervention was consistent patient achievement of an energy expenditure of >10 metabolic equivalents (METs)-h/week through voluntary physical activity.
After 2 years, 69% of the patients in the intervention group (27.1 +/- 2.0 METs x h/week) and 18% of the control group (4.1 +/- 0.8 METs x h/week) achieved the target (P < 0.001) with significant (P < 0.001) improvements in BMI (intervention group 28.9 +/- 0.2 versus control group 30.4 +/- 0.3 kg/m(2)) and HbA(1c) (intervention group 7.0 +/- 0.1 versus control group 7.6 +/- 0.1%).
This randomized, controlled study shows that physicians can motivate most patients with type 2 diabetes to exercise long-term and emphasizes the value of individual behavioral approaches in daily practice.
Increasing prevalence of obesity and disorders associated with sedentary living constitute a major global public health problem. While previous evaluations of interventions to increase physical activity have involved communities or individuals with established disease, less attention has been given to interventions for individuals at risk of disease.
ProActive aims to evaluate the efficacy of a theoretical, evidence- and family-based intervention programme to increase physical activity in a sedentary population, defined as being at-risk through having a parental family history of diabetes. Primary care diabetes or family history registers were used to recruit 365 individuals aged 30-50 years, screened for activity level. Participants were assigned by central randomisation to three intervention programmes: brief written advice (comparison group), or a psychologically based behavioural change programme, delivered either by telephone (distance group) or face-to-face in the family home over one year. The protocol-driven intervention programme is delivered by trained facilitators, and aims to support increases in physical activity through the introduction and facilitation of a range of self-regulatory skills (e.g. goal setting). The primary outcome is daytime energy expenditure and its ratio to resting energy expenditure, measured at baseline and one year using individually calibrated heart rate monitoring. Secondary measures include self-report of individual and family activity, psychological mediators of behaviour change, physiological and biochemical correlates, acceptability, and costs, measured at baseline, six months and one year. The primary intention to treat analysis will compare groups at one-year post randomisation. Estimation of the impact on diabetes incidence will be modelled using data from a parallel ten-year cohort study using similar measures.
ProActive is the first efficacy trial of an intervention programme to promote physical activity in a defined high-risk group accessible through primary care. The intervention programme is based on psychological theory and evidence; it introduces and facilitates the use of self-regulatory skills to support behaviour change and maintenance. The trial addresses a range of methodological weaknesses in the field by careful specification and quality assurance of the intervention programme, precise characterisation of participants, year-long follow-up and objective measurement of physical activity. Due to report in 2005, ProActive will provide estimates of the extent to which this approach could assist at-risk groups who could benefit from changes in behaviours affecting health, and inform future pragmatic trials.
We compared the screening performance of different measures of depression: the standard clinical assessment (SCA); the Beck Depression Inventory (BDI); the Center of Epidemiological Studies-Depression Scale (CES-D); and the Problem Areas in Diabetes (PAID) questionnaire, which assesses diabetes-specific distress. We also studied the ability of these measures to detect diabetes-related distress.
A total of 376 diabetic patients (37.2% type 1; 23.9% type 2 without insulin treatment, 38.8% type 2 with insulin) completed the BDI and CES-D; patients who screened positive participated in a diagnostic interview, the Composite International Diagnostic Interview (CIDI). Also, all patients completed the PAID questionnaire. Results of the SCA that related to depression diagnosis were reviewed to correct for false negative screening results.
The prevalence of clinical depression was 14.1%, with an additional 18.9% of patients receiving a diagnosis of subclinical depression. Sensitivity for clinical depression in SCA (56%) was moderate, whereas BDI, CES-D and the PAID questionnaire showed satisfactory sensitivity (87, 79 and 81%, respectively). For subclinical depression, the sensitivity of the PAID questionnaire (79%) was sufficient, whereas that of SCA (25%) was poor. All methods showed low sensitivity for the detection of diabetes-specific emotional problems (SCA 19%, CIDI 34%, BDI 60%, CES-D 49%).
The screening performance of SCA for clinical and subclinical depression was modest. Additional screening for depression using the PAID or another depression questionnaire seems reasonable. The ability of depression screening measures to identify diabetes-related distress is modest, suggesting that the PAID questionnaire could be useful when screening diabetic patients for both depression and emotional problems.
The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care.
In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside.
This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.
To develop a patient-centred, group-based self-management programme (X-PERT), based on theories of empowerment and discovery learning, and to assess the effectiveness of the programme on clinical, lifestyle and psychosocial outcomes.
Adults with Type 2 diabetes (n = 314), living in Burnley, Pendle or Rossendale, Lancashire, UK were randomized to either individual appointments (control group) (n = 157) or the X-PERT Programme (n = 157). X-PERT patients were invited to attend six 2-h group sessions of self-management education. Outcomes were assessed at baseline, 4 and 14 months.
One hundred and forty-nine participants (95%) attended the X-PERT Programme, with 128 (82%) attending four or more sessions. By 14 months the X-PERT group compared with the control group showed significant improvements in the mean HbA1c (- 0.6% vs. + 0.1%, repeated measures anova, P < 0.001). The number needed to treat (NNT) for preventing diabetes medication increase was 4 [95% confidence interval (CI) 3, 7] and NNT for reducing diabetes medication was 7 (95% CI 5, 11). Statistically significant improvements were also shown in the X-PERT patients compared with the control patients for body weight, body mass index (BMI), waist circumference, total cholesterol, self-empowerment, diabetes knowledge, physical activity levels, foot care, fruit and vegetable intake, enjoyment of food and treatment satisfaction.
Participation in the X-PERT Programme by adults with Type 2 diabetes was shown at 14 months to have led to improved glycaemic control, reduced total cholesterol level, body weight, BMI and waist circumference, reduced requirement for diabetes medication, increased consumption of fruit and vegetables, enjoyment of food, knowledge of diabetes, self-empowerment, self-management skills and treatment satisfaction.
The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews.
Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey.
The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations.
This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended.
OBJECTIVEâTo systematically review the effectiveness of self-management training in type 2 diabetes.RESEARCH DESIGN AND METHODSâMEDLINE, Educational Resources Information Center (ERIC), and Nursing and Allied Health databases were searched for English-language articles published between 1980 and 1999. Studies were original articles reporting the results of randomized controlled trials of the effectiveness of self-management training in people with type 2 diabetes. Relevant data on study design, population demographics, interventions, outcomes, methodological quality, and external validity were tabulated. Interventions were categorized based on educational focus (information, lifestyle behaviors, mechanical skills, and coping skills), and outcomes were classified as knowledge, attitudes, and self-care skills; lifestyle behaviors, psychological outcomes, and quality of life; glycemic control; cardiovascular disease risk factors; and economic measures and health service utilization.RESULTSâA total of 72 studies described in 84 articles were identified for this review. Positive effects of self-management training on knowledge, frequency and accuracy of self-monitoring of blood glucose, self-reported dietary habits, and glycemic control were demonstrated in studies with short follow-up (<6 months). Effects of interventions on lipids, physical activity, weight, and blood pressure were variable. With longer follow-up, interventions that used regular reinforcement throughout follow-up were sometimes effective in improving glycemic control. Educational interventions that involved patient collaboration may be more effective than didactic interventions in improving glycemic control, weight, and lipid profiles. No studies demonstrated the effectiveness of self-management training on cardiovascular diseaseârelated events or mortality; no economic analyses included indirect costs; few studies examined health-care utilization. Performance, selection, attrition, and detection bias were common in studies reviewed, and external generalizability was often limited.CONCLUSIONSâEvidence supports the effectiveness of self-management training in type 2 diabetes, particularly in the short term. Further research is needed to assess the effectiveness of self-management interventions on sustained glycemic control, cardiovascular disease risk factors, and ultimately, microvascular and cardiovascular disease and quality of life.
Objectives To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes. Design Randomised design with participants either attending training immediately (immediate DAFNE) or acting as waiting list controls and attending "delayed DAFNE" training 6 months later. Setting Secondary care diabetes clinics in three English health districts. Participants 169 adults with type 1 diabetes and moderate or poor glycaemic control. Main outcome measures Glycated haemoglobin (HbA 1c), severe hypoglycaemia, impact of diabetes on quality of life (ADDQoL). Results At 6 months, HbA 1c was significantly better in immediate DAFNE patients (mean 8.4%) than in delayed DAFNE patients (9.4%) (t=6.1, P < 0.0001). The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients (t= − 5.4, P < 0.0001), as was the impact of diabetes on overall quality of life (t=2.9, P < 0.01). General wellbeing and treatment satisfaction were also significantly improved, but severe hypoglycaemia, weight, and lipids remained unchanged. Improvements in "present quality of life" did not reach significance at 6 months but were significant by 1 year. Conclusion Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk. This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation.
Objectives: To evaluate whether a course teaching flexible intensive insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes.
Design: randomized design with participants either attending training immediately (immediate DAFNE) or acting as waiting list controls and attending "delayed DAFNE" training 6 months later.
Setting: Secondary care diabetes clinics in three English health districts.
Participants: 169 adults with type 1 diabetes and moderate or poor glycaemic control.
Main outcome measures: Glycated haemoglobin (HbA 1c), severe hypoglycaemia, impact of diabetes on quality of life (ADDQoL).
Results: At 6 months, HbA 1c was significantly better in immediate DAFNE patients (mean 8.4%) than in delayed DAFNE patients (9.4%) (t=6.1, P<0.0001). The impact of diabetes on dietry freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients (t= -5.4, P<0.0001), as was the impact of diabetes on overall quality of life (t = 2.9, P<0.01). General wellbeing and treatment satisfaction were also significantly improved, but severe hypoglycaemia, weight, and lipids remained unchanged. Improvements in "present quality of life" did not reach significance at 6 months but were significant by 1 year.
Conclusion: Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk. This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation.
The present article presents an integrative theoretical framework to explain and to predict psychological changes achieved by different modes of treatment. This theory states that psychological procedures, whatever their form, alter the level and strength of self-efficacy. It is hypothesized that expectations of per- sonal efficacy determine whether coping behavior will be initiated, how much effort will be expended, and how long it will be sustained in the face of ob- stacles and aversive experiences. Persistence in activities that are subjectively threatening but in fact relatively safe produces, through experiences of mastery, further enhancement of self-efficacy and corresponding reductions in defensive behavior. In the proposed model, expectations of personal efficacy are derived from four principal sources of information: performance accomplishments, vicarious experience, verbal persuasion, and physiological states. The more de- pendable the experiential sources, the greater are the changes in perceived self- efficacy. A number of factors are identified as influencing the cognitive processing of efficacy information arising from enactive, vicarious, exhortative, and emotive sources. The differential power of diverse therapeutic procedures is analyzed in terms of the postulated cognitive mechanism of operation. Findings are reported from microanalyses of enactive, vicarious, and emotive modes of treatment that support the hypothesized relationship between perceived self-efficacy and be- havioral changes. Possible directions for further research are discussed.
A home-based exercise programme has been found to be as useful as a hospital-based one in improving cardiovascular fitness after an acute myocardial infarction. To find out whether a comprehensive home-based programme would reduce psychological distress, 176 patients with an acute myocardial infarction were randomly allocated to a self-help rehabilitation programme based on a heart manual or to receive standard care plus a placebo package of information and informal counselling. Psychological adjustment, as assessed by the Hospital Anxiety and Depression Scale, was better in the rehabilitation group at 1 year. They also had significantly less contact with their general practitioners during the following year and significantly fewer were readmitted to hospital in the first 6 months. The improvement was greatest among patients who were clinically anxious or depressed at discharge from hospital. The cost-effectiveness of the home-based programme has yet to be compared with that of a hospital-based programme, but the findings of this study indicate that it might be worth offering such a package to all patients with acute myocardial infarction.
This paper reports on an integrative review of the research literature published between 1983 and 1991 that focused on identifying the determinants of a health-promoting lifestyle. Twenty-three studies were reviewed, six of which were concerned with children and adolescents and the remaining 17 with adults. A meta-analysis of correlations for each study determinant was conducted using the Pandora System. Results indicated that self-efficacy was the strongest predictor of a health-promoting lifestyle, followed by social support, perceived benefits, self-concept, perceived barriers and health definition. The most frequently studied determinants were not the best predictors of a health-promoting lifestyle.
Responsiveness (sensitivity to change over time) is a key psychometric quality for an outcome measure. We examined the responsiveness of the Problem Areas In Diabetes (PAID) questionnaire, a measure of diabetes-specific emotional distress.
PAID data were obtained from seven diabetes intervention studies following a literature search that included both published papers and conference abstracts. To estimate responsiveness we used two indices: (i) a statistical test (the dependent t-test), and (ii) a commonly used effect size index (Cohen's d).
Mean patient PAID scores improved from baseline to follow-up for all seven studies. Specifically, t-statistics ranged from t= 8.5 (P < 0.001) to t= 2.1 (P < 0.06). Effect size results ranged from 0.32 (i.e. small) for a disease management intervention to 0.65 (i.e. moderate) for an intensive medical/educational intervention.
Despite the pilot nature of the studies, the pattern of findings provided strong support for the responsiveness of the PAID. Information on responsiveness helps clinical researchers select measures, accurately estimate sample size to ensure adequate statistical power, and prioritize outcomes to be assessed.
Integrated care for patients who survive a myocardial infarction is lacking. Many patients are not offered cardiac rehabilitation, and secondary prevention is not optimal.
12 month audit of 106 patients who survived an acute myocardial infarction.
Carrick Primary Care Trust in Cornwall (population 98 500) and one district general hospital.
Proportion of patients who complete a cardiac rehabilitation programme after a myocardial infarction. Proportion of patients with optimal secondary prevention, as measured by smoking status, body mass index, cholesterol <5.0 mmol/l, and blood pressure <140/85 mm Hg.
We set up a novel, integrated, and seamless system for cardiac rehabilitation. We employed a cardiac liaison nurse to identify and assess in hospital all patients with suspected acute myocardial infarction. The nurse offered patients the choice of home based rehabilitation with the Heart Manual or hospital based rehabilitation. The nurse gave discharge details to the patient's general practice; these were to be included on a practice based register of coronary heart disease.
All 106 eligible patients were offered cardiac rehabilitation and were included in a practice based register of coronary heart disease to facilitate long term follow up in primary care. 47 (44%) patients chose home based rehabilitation with the Heart Manual, and 41 (87%) of these completed the programme; 35 (33%) patients chose hospital based rehabilitation, and 17 (49%) of these completed the programme. The numbers of patients achieving secondary prevention targets improved significantly: those with serum cholesterol <5.0 mmol/l at discharge increased from 28% at baseline to 75% at 12 months. Optimal care (at least 80-90% uptake of an intervention) was seen with antiplatelet and statin treatments and with smoking cessation. Significantly more patients were prescribed statins at follow up than at baseline (77/106 v 80/91, P=0.005).
National service framework targets for cardiac rehabilitation and secondary prevention can be achieved in patients who survive a myocardial infarction by integrating rehabilitation services (home and hospital) with secondary prevention clinics in primary care. Nurse led clinics in primary care facilitate long term structured care and optimal secondary prevention.
In almost all controlled trials treatments are allocated by randomisation. Blocking and stratification can be used to ensure balance between groups in size and patient characteristics. But stratified randomisation using several variables is not effective in small trials. The only widely acceptable alternative approach is minimisation, a method of ensuring excellent balance between groups for several prognostic factors, even in small samples. With minimisation the treatment allocated to the next participant enrolled in the trial depends (wholly or partly) on the characteristics of those participants already enrolled. The aim is that each allocation should minimise the imbalance across multiple factors.
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