Abstract
Background: Behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar goals, but many do not receive enough support for successful ongoing self-management. After initial education, Medicare reimbursement for diabetes education, commonly delivered on an individual basis, requires physician referral and cannot exceed 2 hours of training per year for a beneficiary, plus 1 hour of nutritional services. We propose to study a novel and more cost-effective approach to improving self-efficacy and outcomes for patients with established type 2 diabetes who are not achieving optimal glycemic control. This randomized trial will formally evaluate the impact of a conversational group-based experience called IDEA (Interactive Dialogue Educational Activity).
Methods: This multi-site, randomized, prospective trial will randomize 621 patients with A1c >7% to one of 3 study groups:
IDEA, 244 patients receive group sessions totaling 8 hours, with an average of 10 patients per group, using conversation maps as a conduit to facilitate dialogue between providers and patients;
Individual Education (IE), 244 patients receive 2 hours with a nurse educator and 1 hour with a dietitian; and
Usual care (UC), 133 patients receive no research intervention.
The primary analyses will involve mixed model regression to assess whether IDEA improves outcomes compared to IE and UC. A1c, blood pressure, and lipids will be evaluated 6 and 12-months post-randomization, and behavioral, emotional, and satisfaction outcomes will be evaluated through survey at baseline, 3, 6, 9 and 12 months. Depending on 12-month results, a longitudinal four year post-intervention analysis is planned to assess sustainability of treatment effects and cost-effectiveness.
Results: Results of this Merck funded trial, expected by June of 2010, could shed landmark evidence on whether education emphasizing interactive group activities can improve diabetes outcomes for patients who are not achieving optimal glycemic control. In addition, the study will assess whether this type of group experience is more effective than more traditional and costly individual education.
Conclusions: Better ways are needed to improve diabetes patient self-management behaviors and outcomes. This rigorously designed study will contribute to knowledge necessary to determine the best content and style of delivery for diabetes education.
- Received September 11, 2008.
