Journey for Control of Diabetes Study (0431-111)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Journey for Control of Diabetes Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652509
• Other study ID #: 0431-111
• Secondary ID: 2008_510
• Status: Completed
• Phase: N/A
• First received: March 31, 2008
• Last updated: April 27, 2017
• Start date: May 1, 2008
• Est. completion date: July 1, 2011

Study information

• Verified date: April 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 621
• Est. completion date: July 1, 2011
• Est. primary completion date: March 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 Diabetes Mellitus

Exclusion Criteria:

• Gestational diabetes

• Type 1 Diabetes Mellitus

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Interactive Dialogue to Educate and Activate (IDEA)
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.
• Individual Education (IE)
IE - patients receive 2 hours with a nurse educator and 1 hour with a dietitian.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program satisfaction, behavioral and emotional outcomes.		3, 6, 9, 12 months after implementation of intervention
Secondary	Blood sugar level, blood pressure, lipids, cost, comorbidities.		6, 12, 18, 24, 36, and 48 months after intervention