-
[show abstract]
[hide abstract]
ABSTRACT: BObjectives: To evaluate whether outcomes from diabetes self-management education for patients with suboptimal control were sustained. Study Design: A randomized controlled trial of 623 adults with type 2 diabetes and glycated hemoglobin (A1C) >7% assigned to receive conventional individual education (IE), group education (GE) using US Diabetes Conversation Maps, or usual care (UC) with no education. Methods: A1C tests, Problem Areas in Diabetes (PAID), Diabetes Self-Efficacy (DES), Recommended Food Score (RFS), physical activity, and medication use were quantified at baseline and 1 year of follow-up through electronic health records and quarterly mailed surveys. Short-term (mean 6.8 months) and long-term (12.8 months) outcomes were evaluated using linear mixed models. In addition, follow-up trajectories were plotted in a random effects generalized additive model with smooth splines. Results: Compared with UC, IE resulted in longterm improved DES and PAID scores (DES, +.11, P = .03 and PAID, -2.94, P = .04), but not significantly improved long-term RFS or physical activity change. The A1C trajectory declined more steeply in IE than GE and UC for the first 150 days post randomization. However, by 250 days, there was no treatment group A1C difference. The model fit likelihood ratio test for A1C intervention trends was significant for 3 distinct non-linear trajectories (P = .02). Conclusions: Conventional IE (but not GE) resulted in significant and sustained improvements in self-efficacy and reduced diabetes distress compared with UC, but short-term improvements in A1C, nutrition, and physical activity were not sustained. Patients may need ongoing reinforcement to achieve lasting behavioral change and glucose control.
The American journal of managed care 02/2013; 19(2):104-12. · 2.46 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Background/Aims For patients with type 2 diabetes of long duration, we evaluated whether improved short-term outcomes obtained through diabetes education were sustained. Methods 623 adults with glycosylated hemoglobin (A1c) greater or equal to 7% were randomized to individual education (IE), group education (GE) using Conversation Maps, or usual care (UC). A1c, Problem Areas in Diabetes (PAID), Diabetes Self-Efficacy (DES), Recommended Food Score (RFS), Physical Activity (PA), and medication intensification (an increase in number of medication classes or insulin start) were evaluated at baseline and at approximately 6 month intervals for the following year using linear mixed models. Results Compared to UC, IE resulted in sustained improved DES and PAID scores in the long-term (DES, +0.11, p=.03 and PAID, -2.94, p=.04), but not significant RFS or PA long-term change. IE resulted in a short-term A1c reduction of .25% (p=.03) and odds ratio (OR) of 1.83 (1.05-3.17) for achieving an A1c < 7% compared with UC, but significant effects were not observed after 6 additional follow-up months. No differences were observed between GE and UC for short-term and long-term DES, PAID, RFS, PA, or A1c. In patients with pharmacy claims data (n=488), odds ratios of medication intensification comparing IE to UC were short-term 0.83(0.44-1.57) and long-term 0.79(0.43-1.47); comparing or GE to UC were short-term 1.22(0.66-2.26) and long-term 0.92(0.50-1.68). Discussion In patients with suboptimal glycemic control, improved measures of self-efficacy and lower diabetes distress observed with IE in the short-term were sustained long-term. However, short-term improvements in glucose control, nutrition, and physical activity were not sustained. Educational interventions did not result in higher medication intensification rates. Results are consistent with most behavior change theories, and suggest greater attention to maintenance and relapse, possibly from continued ongoing support from educators, may be needed to sustain improvements in healthy behaviors and glucose control.
Clinical Medicine & Research 08/2012; 10(3):161.
-
JoAnn Sperl-Hillen,
Sarah Beaton, Omar Fernandes,
Ann Von Worley,
Gabriela Vazquez-Benitez,
Emily Parker,
Ann Hanson,
Jodi Lavin-Tompkins,
Patricia Glasrud,
Herbert Davis,
Kenneth Adams,
William Parsons,
C Victor Spain
[show abstract]
[hide abstract]
ABSTRACT: Group education for patients with suboptimally controlled diabetes has not been rigorously studied.
A total of 623 adults from Minnesota and New Mexico with type 2 diabetes and glycosylated hemoglobin (HbA(1c)) concentrations of 7% or higher were randomized to (1) group education (using the US Diabetes Conversation Map program), (2) individual education, or (3) usual care (UC; ie, no assigned education). Both education methods covered content as needed to meet national standards for diabetes self-management education and were delivered through accredited programs from 2008 to 2009. General linear mixed-model methods assessed patient-level changes between treatment groups in mean HbA(1c) levels from baseline to follow-up at 6.8 months. Secondary outcomes included mean change in general health status (Medical Outcomes Study 12-Item Short Form Health Survey [SF-12]), Problem Areas in Diabetes (PAID), Diabetes Self-Efficacy (DES-SF), Recommended Food Score (RFS), and Physical Activity (PA, min/wk).
Mean HbA(1c) concentration decreased in all groups but significantly more with individual (-0.51%) than group education (-0.27%) (P = .01) and UC (-0.24%) (P = .01). The proportion of subjects with follow-up HbA(1c) concentration lower than 7% was greater for individual education (21.2%) than for group (13.9%) and UC (12.8%) (P = .03). Compared with UC, individual education (but not group) improved SF-12 physical component score (+1.88) (P = .04), PA (+42.95 min/wk) (P = .03), and RFS (+0.63) (P = .05). Compared with group education, individual education reduced PAID (-3.62) (P = .02) and increased self-efficacy (+0.1) (P = .04).
Individual education for patients with established suboptimally controlled diabetes resulted in better glucose control outcomes than did group education using Conversation Maps. There was also a trend toward better psychosocial and behavioral outcomes with individual education.
clinicaltrials.gov Identifier: NCT00652509.
Archives of internal medicine 12/2011; 171(22):2001-10. · 11.46 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Background/Aims 'Journey for Control of Diabetes: The IDEA Study' is an ongoing randomized trial evaluating the efficacy of group diabetes education (GE) using US Diabetes Conversation MapsTM and conventional individual diabetes education (IE) among adults with sub-optimally controlled Type 2 diabetes (A1c>=7%). The study is being conducted at 2 sites, Minneapolis, MN, and Albuquerque, NM. Because the 2 sites are regions with diverse demographic characteristics, the goal of this paper was to identify differences in the main outcome (A1c) between sites. Methods In addition to A1c>=7, study inclusion criteria were patients who were diagnosed with diabetes, and were diabetes education-naive within the last one to two years. Consenting patients were randomly assigned to receive either: GE, IE or usual care (UC) as recommended by the primary care provider. All education was provided through each care system's ADA-recognized education program. Follow-up A1c levels were obtained from electronic laboratory data. Differences in A1c levels were evaluated using Generalized Linear Models (SAS 9.2). Results There were 623 patients enrolled: 337 from MN and 286 from NM. Sample demographics were: mean age of 60.0 (MN) and 64.0 (NM); percent female, 44.8 (151/337) for MN and 54.9 (157/286) for NM; race/ethnicity, 81.1% (276/337) white, 8.1% (27/337) black, 3.6% (12/337) Hispanic, and 7.2% (24/337) other for MN, and NM 45.6% (130/286) white, 2.5% (7/286) black, 43.9% (126/286) Hispanic, and 8.1% (23/286) other. Mean baseline A1c was 8.1% for MN and 8.3% for NM. There was a significant difference in percentages of patients having an A1c in the post-randomization follow-up period (approximately 6 months), 89.0% (300/337) for MN and 67.5% (193/286) for NM. Of those with an A1c test, NM patients had a significantly greater A1c reduction with GE (-0.947 for NM vs. -0.136 for MN), IE (-1.093 for NM vs. -0.497 for MN), and UC (-0.700 for NM vs. -0.253 for MN), (p<.0001). Conclusions Although it appears that IE and GE were more effective for NM patients compared to MN, the large number of NM patients without A1c values in the follow-up period makes any conclusions tentative. The long-term data analysis is pending and should provide a more definitive conclusion.
Clinical Medicine & Research 11/2011; 9(3-4):164-165.
-
Joann Sperl-Hillen,
Sarah Beaton, Omar Fernandes,
Jodi Lavin-Tompkins,
Ann Von Worley,
Emily Parker,
Ann Hanson,
Patricia Glasrud,
Herbert Davis,
Kenneth Adams,
William Parsons,
Vic Spain
[show abstract]
[hide abstract]
ABSTRACT: Background/Aims Group diabetes education for patients is cost-efficient and could be more effective than an individual approach. The objective is to determine whether outcomes of group education are comparable to individual education in the short-term. Methods We identified 9,971 patients from two healthcare systems, ABQ Health Partners in New Mexico and HealthPartners in Minnesota, through electronic health records (EHR) with type 2 diabetes (T2DM) diagnostic codes and sub-optimal blood sugar control (A1c > 7%). Invitations were mailed from June 2008 - May 2009 and 623 (6.2% participation) subjects were randomized to: Individual Education (IE), Group Education (GE), or Usual Care (UC)/no education. Education was delivered through the American Diabetes Association-recognized education programs of the participant's care system. IE used a conventional approach with three 1-hr sessions, and GE used four 2-hr sessions using the U.S. Diabetes Conversation Map(®) education program. Psychosocial and behavioral measures were survey-assessed at baseline, 1, and 4 months after the last scheduled educational session. Clinical measures were obtained through the patient's EHR in the 6 months preceding baseline & randomization and preceding the second follow-up survey. General and linear mixed modeling methods were used to assess patient changes from baseline to follow-up in A1c, General Health Status (SF-12), Problem Areas in Diabetes (PAID), Diabetes Empowerment Scale (DES), components of the Diabetes Care Profile (DCP), Readiness to Change (RTC), Recommended Food Score (RFS), and physical activity (PA) using the BRFSS. Results At follow-up, the mean A1c for IE decreased .61% (p<.001), .36% for GE (p=.003) and .34% for UC (p=.01). The A1c for IE decreased by .27% compared to UC (p=.02) and .25% compared to GE (p=.01). Compared to UC, mean PAID was reduced by IE (-.37, p=.02) and GE (-.30, p=.05) and SF12 physical health score, PA, and RFS were increased by IE 1.98 (p=.03), 41.17 minutes/ week (p=.05), and.62 (p=.06), respectively. DES, RTC, and DCP were not significantly changed by IE or GE. Conclusion At 4 months post-education completion, individual education for this patient population resulted in improved A1c's compared to usual care and group education. Diabetes-specific distress (PAID score) was reduced with both methods of education.
Clinical Medicine & Research 11/2011; 9(3-4):162.
-
Kenneth Adams,
Sarah Beaton,
Emily Parker,
Jodi Lavin-Tompkins,
Joann Sperl-Hillen,
Ann Hanson,
Herbert Davis, Omar Fernandes,
Ann Von Worley,
Patricia Glasrud,
William Parsons,
Vic Spain
[show abstract]
[hide abstract]
ABSTRACT: Background/Aims Participant non-adherence to study protocols can adversely affect clinical trials by reducing statistical power. Similarly non-adherence is an important issue in clinical practice. Ceasing to participate is one form of non-adherence. Subject characteristics appear to influence adherence. We evaluated relationships between subject characteristics and completion of educational sessions in IDEA, a clinical trial testing 2 modes of diabetes education in patients with sub-optimal diabetes control. Methods IDEA eligibility criteria included Type 2 diabetes, A1c =7%, and no recent diabetes education. Subjects (n=623) were randomly allocated to one of 3 diabetes education treatment arms; individual education, group education, or a comparison group with no active intervention. Individual education consisted of three 1-hour sessions, following an AADE program. Group education was delivered in four 2-hour group sessions that emphasized patient interaction. Subjects were considered adherent if they completed all assigned sessions. At the end of the study, tracking data indicated completion rates of 72.0% (175/243) in the group education intervention and 86.1% (211/245) in the individual treatment intervention. We sought to identify demographic, psychosocial and clinical characteristics that might explain non-completion. We hypothesized that, within each arm, baseline health status (SF-12 mental composite and physical composite scores), depression (PHQ9), personality type (TIPI Big 5; extraversion, agreeability, emotional stability, conscientiousness, and openness), and Hb A1c level were associated with completion. Results In the group education arm, subjects scoring higher on the emotional stability scale were more likely to complete (p<0.05). Generally, demographic factors were more strongly associated with completion of group education than were psychosocial or clinical factors: women and older subjects were more likely to complete than men and younger subjects (gender, p=0.008; age, p=<0.0005). Within the individual education arm, completion was predicted by higher physical health score (SF12-PCS; p=0.005), higher mental health scales (SF12-MCS, p=0.008), lower depression score (PHQ9, p=0.002), and lower Hb A1c (p<0.05). However, neither gender nor age was associated with completion. Conclusions Factors related to study completion appear to differ between the 2 diabetes educational interventions. These results may be relevant to diabetes educational programs considering strategies to improve "no show" and lack of completion rates.
Clinical Medicine & Research 11/2011; 9(3-4):164.
-
[show abstract]
[hide abstract]
ABSTRACT: Aims: In order to improve self- efficacy and clinical outcomes for people with diabetes, new approaches using more interactive methods of group education are being promoted. We report results of an educator evaluation of IDEA to assist others who may be interested in starting similar groups in their care settings. Methods: A qualitative analysis was conducted as part of an ongoing randomized trial comparing two different educational interventions (Group IDEA and Individual Education) to Usual Care. As part of the study, educators at HealthPartners clinics in Minneapolis, MN and ABQ Health Partners in Albuquerque, NM were trained on how to use Conversation Maps (CM). All educators completed a Likert scale questionnaire after each CM session with responses from 1-10 (10 being the best). An open- ended evaluation form was also used to solicit positive and negative opinions about the sessions. Analysis: The data consisted of 48 nurse and dietitian evaluations from two sites. The mean Likert scores of the educational experience were calculated and compared for each site and for each of the four CM topics (general information, monitoring, nutrition, and complications). All eight research team members also reviewed answers to the open-ended questions and group consensus was used to describe positive and negative themes. Results: Educator rated Likert scores of map sessions were excellent (mean scores for Maps 1, 2, 3, 4: Overall success 8.3, 7.6, 7.7, 8.8; Ease and comfort levels in facilitation 8.9, 8.9, 9.2, 9.5; Patient motivation to self-manage 7.7, 6.9, 8, 8.8). Scores did not differ significantly across sites or between maps. Positive comments on the maps outweighed the negatives. The challenges identified were: Disruptive (especially angry or negative) people; Distracting topics raised by patients and late arrivals; Variable reading levels among patients (too hard or too easy); and Not enough time to cover the content (especially nutrition). Conclusions: The IDEA method was perceived positively by educators due to its ability to promote patient interaction, sharing, and meaningful discussion. To be successful, however, educators need tips and practice on handling disruptive patients, distractions, variance in literacy, and covering intended nutritional content in a group context.
Clinical Medicine & Research 03/2010; 8(1):47.
-
[show abstract]
[hide abstract]
ABSTRACT: Background and Aims: The pace of recruitment impacts resources, planned study tasks, timelines, and ultimately, costs. The Journey for Control of Diabetes: the IDEA Study, a randomized trial conducted in two healthcare settings (Minnesota and New Mexico) utilized different recruitment methods at each site. This presentation compares these recruitment methods with respect to recruitment efficiency and costs.
-
[show abstract]
[hide abstract]
ABSTRACT: Background and Aims: The Journey for Control of Diabetes: the IDEA Study, a randomized clinical study, is evaluating the effectiveness of an interactive, group-based learning experience using Conversation Maps™. Patients with uncontrolled diabetes were sent letters describing the study and subsequently contacted to assess eligibility and interest. Recruitment, estimated to take 5 months, was extended to 11 months due to difficulties in obtaining a committed group of eligible participants. Because of these recruitment difficulties, we examined differences between the enrolled subgroup and those who indicated they were not interested in participation in an attempt to identify patient characteristics of those who enrolled.
-
Omar Fernandes
[show abstract]
[hide abstract]
ABSTRACT: Background and Aims: The main purpose of this NIDDK-funded group-randomized trial is to evaluate the effect of teaching resident physicians fundamental principles of diabetes management using an interactive computer simulation program called SimCare. A minimum of 20 primary care residency programs with up to 700 residents total will be randomly assigned to either (a) an early SimCare Diabetes learning program group or (b) a delayed SimCare Diabetes learning program group. This presentation will provide an explanation of and justification for using an online informed consent process to facilitate informed consent for a national trial of this scale.
