[Show abstract][Hide abstract] ABSTRACT: Background:
Although monitoring foot skin temperatures has been associated with diabetic foot ulcer recurrence, no studies have been carried out to test the feasibility among European Caucasians. Moreover, the educational and/or motivational models that promote cognitive or psychosocial processes in these studies are lacking. Thus, we conducted a pilot randomized controlled trial to test the feasibility of monitoring foot skin temperatures in combination with theory-based counselling to standard foot care to reduce diabetic foot ulcer recurrence.
In a single-blinded nurse-led 1-year controlled trial, conducted at a hospital setting in Norway, 41 patients with diabetic neuropathy and previous foot ulcer were randomized to the intervention (n = 21) or control groups (n = 20). All participants were instructed in foot care and recording observations daily. Additionally, the intervention group was taught how to monitor and record skin temperature at baseline, and received counselling every third month supporting them to use the new treatment. Subjects observing temperature differences >2.0 °C between corresponding sites on the left and right foot on two consecutive days were asked to contact the study nurse and reduce physical activity. Fisher exact test was used to evaluate the effect of the intervention on the proportion of subjects with a foot ulcer. Kaplan-Meier survival analysis was performed to compare the two groups in regard to the time to development of a foot ulcer.
In the intervention group, 67 % (n = 14/21) monitored and recorded skin temperatures ≥80 % of the time while 70 % (n = 14/20) of the controls recorded foot inspections. Foot ulcer incidence was 39 % (7/21) vs. 50 % (10/20) in the intervention and control groups, respectively (ns).
This feasibility study showed that the addition of counselling to promote self-monitoring of skin temperature to standard care to prevent recurrence of foot ulcer is feasible in patients with diabetes in Norway. Home skin temperature monitoring was performed as frequently by the intervention group as usual foot observations in the controls despite the extra effort required. We did not detect a difference in foot ulcer recurrence between groups, but our study may inform future full scale studies.
[Show abstract][Hide abstract] ABSTRACT: Self-management is crucial in the daily management of type 2 diabetes. It has been suggested that mHealth may be an important method for enhancing self-management when delivered in combination with health counseling.
The objective of this study was to test whether the use of a mobile phone-based self-management system used for 1 year, with or without telephone health counseling by a diabetes specialist nurse for the first 4 months, could improve glycated hemoglobin A1c (HbA1c) level, self-management, and health-related quality of life compared with usual care.
We conducted a 3-arm prospective randomized controlled trial involving 2 intervention groups and 1 control group. Eligible participants were persons with type 2 diabetes with an HbA1c level ≥7.1% (≥54.1 mmol/mol) and aged ≥18 years. Both intervention groups received the mobile phone-based self-management system Few Touch Application (FTA). The FTA consisted of a blood glucose-measuring system with automatic wireless data transfer, diet manual, physical activity registration, and management of personal goals, all recorded and operated using a diabetes diary app on the mobile phone. In addition, one intervention group received health counseling based on behavior change theory and delivered by a diabetes specialist nurse for the first 4 months after randomization. All groups received usual care by their general practitioner. The primary outcome was HbA1c level. Secondary outcomes were self-management (heiQ), health-related quality of life (SF-36), depressive symptoms (CES-D), and lifestyle changes (dietary habits and physical activity). Data were analyzed using univariate methods (t test, ANOVA) and multivariate linear and logistic regression.
A total of 151 participants were randomized: 51 to the FTA group, 50 to the FTA-health counseling (FTA-HC) group, and 50 to the control group. Follow-up data after 1 year were available for 120 participants (79%). HbA1c level decreased in all groups, but did not differ between groups after 1 year. The mean change in the heiQ domain skills and technique acquisition was significantly greater in the FTA-HC group after adjusting for age, gender, and education (P=.04). Other secondary outcomes did not differ between groups after 1 year. In the FTA group, 39% were substantial users of the app; 34% of the FTA-HC group were substantial users. Those aged ≥63 years used the app more than their younger counterparts did (OR 2.7; 95% CI 1.02-7.12; P=.045).
The change in HbA1c level did not differ between groups after the 1-year intervention. Secondary outcomes did not differ between groups except for an increase in the self-management domain of skill and technique acquisition in the FTA-HC group. Older participants used the app more than the younger participants did.
[Show abstract][Hide abstract] ABSTRACT: Self-management support for people with type 2 diabetes is essential in diabetes care. Thus, mobile health technology with or without low-intensity theory-based health counseling could become an important tool for promoting self-management.
The aim was to evaluate whether the introduction of technology-supported self-management using the Few Touch Application (FTA) diabetes diary with or without health counseling improved glycated hemoglobin (HbA1c) levels, self-management, behavioral change, and health-related quality of life, and to describe the sociodemographic, clinical, and lifestyle characteristics of the participants after 4 months.
A 3-armed randomized controlled trial was conducted in Norway during 2011-2013. In the 2 intervention groups, participants were given a mobile phone for 1 year, which provided access to the FTA diary, a self-help tool that recorded 5 elements: blood glucose, food habits, physical activity, personal goal setting, and a look-up system for diabetes information. One of the intervention groups was also offered theory-based health counseling with a specialist diabetes nurse by telephone for 4 months from baseline. Both intervention groups and the control group were provided usual care according to the national guidelines. Adults with type 2 diabetes and HbA1c ≥7.1% were included (N=151). There were 3 assessment points: baseline, 4 months, and 1 year. We report the short-term findings after 4 months. HbA1c was the primary outcome and the secondary outcomes were self-management (Health Education Impact Questionnaire, heiQ), behavioral change (diet and physical activity), and health-related quality of life (SF-36 questionnaire). The data were analyzed using univariate methods (ANOVA), multivariate linear, and logistic regression.
Data were analyzed from 124 individuals (attrition rate was 18%). The groups were well balanced at baseline. There were no differences in HbA1c between groups after 4 months, but there was a decline in all groups. There were changes in self-management measured using the health service navigation item in the heiQ, with improvements in the FTA group compared to the control group (P=.01) and in the FTA with health counseling group compared with both other groups (P=.04). This may indicate an improvement in the ability of patients to communicate health needs to their health care providers. Furthermore, the FTA group reported higher scores for skill and technique acquisition at relieving symptoms compared to the control group (P=.02). There were no significant changes in any of the domains of the SF-36.
The primary outcome, HbA1c, did not differ between groups after 4 months. Both of the intervention groups had significantly better scores than the control group for health service navigation and the FTA group also exhibited improved skill and technique acquisition.
[Show abstract][Hide abstract] ABSTRACT: The present study protocol is designed to cover the Norwegian part of the European Union Collaborative Project-REgioNs of Europe WorkINg together for HEALTH (RENEWING HEALTH). Self-management support is an important element of care for persons with type 2 diabetes (T2D) for achieving metabolic control and positive lifestyle changes. Telemedicine (TM) with or without health counseling may become an important technological aid for self-management and may provide a user-centered model of care. In spite of many earlier studies on TM, there remains a lack of consensus in research findings about the effect of TM interventions.
The aim of RENEWING HEALTH is to validate and evaluate innovative TM tools on a large scale through a common evaluation, making it easier for decision makers to choose the most efficient and cost-effective technological interventions. The Norwegian pilot study evaluates whether the introduction of a mobile phone with a diabetes diary application together with health counseling intervention produces benefits in terms of the desired outcomes, as reflected in the hemoglobin A1c level, health-related quality of life, behavior change, and cost-effectiveness.
The present study has a mixed-method design comprising a three-armed prospective randomized controlled trial and qualitative interviews with study data collected at three time points: baseline, after 4 months, and after 1 year. The patients' registrations on the application are recorded continuously and are sent securely to a server.
The inclusion of patients started in March 2011, and 100% of the planned sample size is included (N=151). Of all the participants, 26/151 patients (17.2%) are lost to follow-up by now, and 11/151 patients (7.3%) are still in the trial. Results of the study protocol will be presented in 2014.
The key goals of this trial are to investigate the effect of an electronic diabetes diary app with and without health counseling, and to determine whether health counseling is important to the continued use of the application and the patients' health competence and acceptability. Research within this area is needed because few studies have investigated the effectiveness of apps used in long-term interventions with this degree of self-management.
Clinicaltrials.gov NCT01315756; http://clinicaltrials.gov/ct2/show/NCT01315756 (Archived by WebCite at http://www.webcitation/6BTyuRMpH).
[Show abstract][Hide abstract] ABSTRACT: Background
This study tests the hypotheses that health-related quality of life (HRQOL) in prevalent dialysis patients with diabetes is lower than in dialysis patients without diabetes, and is at least as poor as diabetic patients with another severe complication, i.e. foot ulcers. This study also explores the mortality risk associated with diabetes in dialysis patients.
HRQOL was assessed using the Short Form-36 Health Survey (SF-36), in a cross-sectional study of 301 prevalent dialysis patients (26% with diabetes), and compared with diabetic patients not on dialysis (n = 221), diabetic patients with foot ulcers (n = 127), and a sample of the general population (n = 5903). Mortality risk was assessed using a Kaplan-Meier plot and Cox proportional hazards analysis.
Self-assessed vitality, general and mental health, and physical function were significantly lower in dialysis patients with diabetes than in those without. Vitality (p = 0.011) and general health (p <0.001) was impaired in diabetic patients receiving dialysis compared to diabetic patients with foot ulcers, but other subscales did not differ. Diabetes was a significant predictor for mortality in dialysis patients, with a hazard ratio (HR) of 1.6 (95% CI 1.0-2.5) after adjustment for age, dialysis vintage and coronary artery disease. Mental aspects of HRQOL were an independent predictor of mortality in diabetic patients receiving dialysis after adjusting for age and dialysis vintage (HR 2.2, 95% CI 1.0-5.0).
Physical aspects of HRQOL were perceived very low in dialysis patients with diabetes, and lower than in other dialysis patients and diabetic patients without dialysis. Mental aspects predicted mortality in dialysis patients with diabetes. Increased awareness and measures to assist physical function impairment may be particularly important in diabetes patients on dialysis.
[Show abstract][Hide abstract] ABSTRACT: To describe health-related quality of life in diabetes outpatients and investigate the impact of diabetic foot ulcers, by comparing a group of patients with and without diabetic foot ulcers complications. Secondary to study the impact of sociodemographic and clinical variables in the two groups.
The study involved 130 diabetes outpatients and 127 diabetic foot ulcers patients. Health-related quality of life was measured with the generic questionnaire Short Form-36, consisting of eight dimensional scores. All scores were adjusted for differences in age and gender (estimated marginal means). Differences were compared with anova calculations, by the use of Predictive Analytics Software, PASW (version 17.0).
This study confirms that health-related quality of life differs significantly between disease subgroups when measured with Short Form-36. Diabetic foot ulcers had a major negative impact on 7/8 subscales on the Short Form-36 compared to the diabetes outpatients group. health-related quality of life decreased with increasing amount of complications and comorbidity in the diabetes outpatients group, with cardiovascular complications being the most pronounced predictor of lower health-related quality of life scores.
Patients who have developed diabetic foot ulcers reports much poorer health-related quality of life than compared to diabetes outpatients. Factors linked to the development of late complications were not detected in the diabetic foot ulcers group, such as cardiovascular comorbidity and neuropathy.
Health-related quality of life measurement in early stages of disease may detect patients at risk of a more serious disease course and who consequently are in need of a more intensive follow-up.
[Show abstract][Hide abstract] ABSTRACT: This chapter reviews the research conducted on patients with diabetes and foot ulcers and their health-related quality of life (HRQL). Patients with diabetic foot ulcers (DFU) report a poor HRQL, and physical impairment especially influences the patients’ HRQL. The instruments used to measure HRQL in patients with DFU vary in number and the characterization of the dimensions they assess. The instruments used are both generic, such as the SF-36, and disease-specific, such as the Diabetic Foot Ulcer Scale–Short Form (DFS–SF) for patients with DFU, the Cardiff Wound Impact Scale (CWIS) for patients with chronic ulcers in general, and the Neuropathy- and Foot Ulcer-Specific Quality of Life Instrument (NeuroQoL) for patients with foot problems and peripheral neuropathy. Whereas the questions in the generic instruments ask the individual to evaluate her/his physical, social, and mental health in general terms, the disease-specific instruments ask about issues specific to foot problems and foot ulcers. Additional work is needed to further develop and test the validated tools in different countries throughout the world. A future challenge is the administration of HRQL questionnaires to individual DFU patients in clinical practice, and to use these data, together with other patient-reported outcomes, to improve communication between patients and health-care providers, patient care, and patient well-being.
Handbook of Disease Burdens and Quality of Life Measures, 01/2010: pages 2115-2134; , ISBN: 978-0-387-78664-3
[Show abstract][Hide abstract] ABSTRACT: The objectives of this study were to assess ulcer healing in patients with diabetic foot ulcers during a 1-year follow-up, to compare health-related quality of life (HRQL) between those with healing ulcers and those with ulceration, and to assess whether changes in healing affect patients' HRQL.
Data were collected at baseline, after 6 months (T(2)), and after 12 months (T(3)). Adult patients (n=127) with type 1 or type 2 diabetes and foot ulcers were recruited from outpatient clinics. Self-assessed HRQL was measured using the SF-36 Health Survey at all measurement points. Sociodemographic and clinical data were obtained at baseline, and data on healing, ulceration, and amputation were obtained at T(2) and T(3).
Of 127 patients included at baseline, 35% had persistent ulcer, 37% had healed ulcer, 6% had undergone amputation, and 7% had died at T(3). In addition, 9% had undergone amputation at T(2). Significant differences were observed between patients with healed ulcers and patients with persistent ulcers on general health at baseline; on physical functioning, general health, and social functioning at T(2); and on five of eight subscales in the SF-36 (e.g., physical functioning, role limitation--physical, general health, social functioning, and mental health) and on the physical summary score at T(3). Furthermore, HRQL improved significantly in social functioning and mental health in parallel with healing of ulcers, and deteriorated in the social functioning subscale in parallel with nonhealing of ulcers.
Only 37% of ulcers healed during the 1-year follow-up. Poor HRQL during follow-up was associated with poor ulcer prognosis.
Journal of diabetes and its complications 05/2008; 22(6):400-7. DOI:10.1016/j.jdiacomp.2007.06.006 · 3.01 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The purpose of the study was to describe the sociodemographic variables, clinical characteristics, and treatment factors in patients with diabetic foot ulcers (DFU) and to explore the associations between these factors and the patients' health-related quality of life (HRQL).
Cross-sectional data were obtained from 127 patients consecutively recruited from six hospital outpatient clinics. The patients were over 20 years of age, had current DFU, and had been diagnosed with diabetes of either Type 1 or Type 2. Data were obtained by clinical and laboratory examination and by self-completed questionnaires (SF-36). Descriptive analyses, bivariate analyses, and hierarchical regression analyses in three blocks were performed.
The patients' mean age was 60 years (S.D., 13.8 years); 72% were men, and 29% had Type 1 diabetes. The most important variables explaining the variance in HRQL were the presence of biochemical signs of inflammation as measured by the detection of C-reactive protein (CRP) >10 mg/l, an ankle-brachial index (ABI) <0.9, an ulcer size > or =5 cm(2), nephropathy, and a body mass index <25 kg/m(2). The strongest association occurred between biochemical signs of inflammation CRP >10 mg/l, ABI <0.9, ulcer size >5 cm(2), and HRQL on physical functioning (adjusted r(2)=24). A major part of the variance remained unexplained and should be investigated in future studies.
The findings may tend to identify the most vulnerable subgroups among those with DFU and may be useful in the formulation of strategies to improve function and HRQL in these patients.
Journal of Diabetes and its Complications 07/2007; 21(4):227-36. DOI:10.1016/j.jdiacomp.2007.02.001 · 3.01 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this study was to describe health-related quality-of-life (HRQL) in patients with diabetic foot ulcers by comparing their HRQL with that of a sample from the general population without diabetes (general population) and a subgroup with diabetes (diabetes population), and to examine the differences between groups by sociodemographic characteristics and lifestyle factors.
A cross-sectional study was made of 127 adults with current diabetic foot ulcer, recruited from six hospital outpatient clinics, a control sample categorized as a diabetes population (n = 221) from the Norwegian Survey of Level of Living, and a sample from the general population (n = 5903). Data on sociodemographic characteristics (sex, age, cohabitation, education and employment) and lifestyle (body mass index [BMI] and smoking status) and HRQL (SF-36) were obtained.
In all the SF-36 subscales and in the two SF-36 summary scales, the patients with diabetic foot ulcer reported significantly poorer HRQL than the diabetes population. The most striking differences were for role limitation-physical (32.1 vs. 62.2, p < 0.001), physical functioning (57.5 vs. 77.3, p < 0.001) and role limitation-emotional (57.4 vs. 72.0, p < 0.001). The patients with foot ulcer had significantly lower HRQL than the general population on all scales, and in particular on role limitation-physical (32.1 vs. 74.3, p < 0.001), physical functioning (57.5 vs. 85.2, p < 0.001) and general health (50.1 vs. 74.3, p < 0.001). The most important sociodemographic characteristic that differed between the diabetic foot ulcer patients and the diabetes population was that significantly more of the foot ulcer patients were men living alone. The largest differences between the foot ulcer patients and the general population were that more of the foot ulcer patients were men, older, living alone, less well educated, and not working. The diabetic foot ulcer patients, the diabetes population and the general population differed in BMI: 28 kg/m(2) in the foot ulcer patients, 27 kg/m(2) in the diabetes population and 25 kg/m(2) in the general population.
Diabetic foot ulcer patients had much worse HRQL compared with the diabetes population and the general population, especially in physical health. Foot ulcer patients were more often men living alone, and obesity was a problem in both the foot ulcer patients and the diabetes population.
Quality of Life Research 03/2007; 16(2):179-89. DOI:10.1007/s11136-006-0031-y · 2.49 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: This study describes the prevalence and occurrence of diabetic foot ulcer (DFU) pain and the impact of DFU pain on health-related quality of life (HRQL) using generic and disease specific instruments. Data were obtained from 127 patients with DFU who were recruited from 6 hospital-based diabetic outpatient clinics. HRQL was measured using the Medical Outcome Study-Short Form (SF-36) and the Diabetes Foot Ulcer Scale (DFS). Occurrence of pain was assessed using 2 items from the DFS (ie, pain while walking and/or standing and pain during the night related to foot ulcer problems). Seventy-five percent reported some pain related to DFU and 57% reported DFU pain while walking and/or standing and also during the night. Twenty-five percent reported pain none of the time. A higher percentage of patients with pain reported having a prescription for an analgesic medication than those without pain. Patients who reported pain most or all of the time had statistically and clinically significantly poorer HRQL than those who did not report pain. These findings suggest that pain associated with DFU is a significant clinical problem. Additional research is warranted to further characterize the pain associated with DFU and its impact on patient outcomes and HRQL. PERSPECTIVE: Numerous basic and clinical studies have focused on pain associated with diabetic peripheral neuropathy. Findings from this study suggest a new pain problem in patients with diabetes, namely, pain associated with foot ulcers, that warrants further investigation.
Journal of Pain 05/2006; 7(4):290-9. DOI:10.1016/j.jpain.2005.12.002 · 4.01 Impact Factor