Journey for Control of Diabetes Study (0431-111)

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Individual Education (IE); Behavioral: Interactive Dialogue to Educate and Activate (IDEA)

• Registration Number: NCT00652509
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Behavior change and self-efficacy are key for patients with diabetes to sustain blood sugar goals, but most care systems do not provide effective support to assist patients in successful ongoing self-management. After initial education, many programs are limited by allowable Medicare reimbursement for diabetes education which currently requires physician referral and cannot exceed two hours of training per year for a beneficiary, plus one hour of nutritional services. These services are usually provided either on an individual basis or occasionally through a traditional group class approach. For patients with established type 2 diabetes who are not achieving optimal glycemic control, we propose to develop and formally evaluate in a randomized trial a novel group experience to educate and motivate patients with established type 2 called IDEA, (Interactive Dialogue to Educate and Activate). This multi-site, randomized, prospective trial will randomize 621 patients with inadequately blood sugar control levels to one of 3 study groups: (1) IDEA - 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 (2) Individual Education (IE) - patients receive 2 hours with a nurse educator and 1 hour with a dietitian, and (3) Usual care (UC)- patients receive no research intervention. The primary analyses will involve mixed model regression to assess whether IDEA improves outcomes compared to IE and UC. Blood sugar level, blood pressure, and lipids will be evaluated 6 and12 months post-randomization and behavioral, emotional, and satisfaction outcomes 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-03
• Study Start: 2008-05-01
• Primary Completion: 2010-03-01
• Study Completion: 2011-07-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 621

Inclusion Criteria

• Type 2 Diabetes Mellitus

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Exclusion Criteria

• Gestational diabetes
• Type 1 Diabetes Mellitus

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Individual Education (IE)	IE
1	Interactive Dialogue to Educate and Activate (IDEA)	IDEA

Primary Outcome Measures

Name	Time	Method
Program satisfaction, behavioral and emotional outcomes.	3, 6, 9, 12 months after implementation of intervention

Secondary Outcome Measures

Name	Time	Method
Blood sugar level, blood pressure, lipids, cost, comorbidities.	6, 12, 18, 24, 36, and 48 months after intervention