Journey for Control of Diabetes Study (0431-111)

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00652509

Collaborator

(none)

621

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Behavioral: Interactive Dialogue to Educate and Activate (IDEA) Behavioral: Individual Education (IE)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

621 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Journey for Control of Diabetes Study

Actual Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 IDEA	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.
Active Comparator: 2 IE	Behavioral: Individual Education (IE) IE - patients receive 2 hours with a nurse educator and 1 hour with a dietitian.
No Intervention: 3 UC: Patients receive no research intervention.

Arm

Intervention/Treatment

Experimental: 1

IDEA

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.

Active Comparator: 2

Behavioral: Individual Education (IE)

IE - patients receive 2 hours with a nurse educator and 1 hour with a dietitian.

No Intervention: 3

UC: Patients receive no research intervention.

Outcome Measures

Primary Outcome Measures

Program satisfaction, behavioral and emotional outcomes. [3, 6, 9, 12 months after implementation of intervention]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 Diabetes Mellitus

Exclusion Criteria:

Gestational diabetes
Type 1 Diabetes Mellitus

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Merck Sharp & Dohme LLC

Investigators

Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merck Sharp & Dohme LLC

ClinicalTrials.gov Identifier:

NCT00652509

Other Study ID Numbers:

0431-111
2008_510

First Posted:

Apr 3, 2008

Last Update Posted:

Apr 28, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Apr 28, 2017