Journey for Control of Diabetes Study (0431-111)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00652509
First received: March 31, 2008
Last updated: August 29, 2012
Last verified: August 2012
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Behavioral: Interactive Dialogue to Educate and Activate (IDEA)
Behavioral: Individual Education (IE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Journey for Control of Diabetes Study

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Program satisfaction, behavioral and emotional outcomes. [ Time Frame: 3, 6, 9, 12 months after implementation of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood sugar level, blood pressure, lipids, cost, comorbidities. [ Time Frame: 6, 12, 18, 24, 36, and 48 months after intervention ] [ Designated as safety issue: No ]

Enrollment: 621
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes Mellitus

Exclusion Criteria:

  • Gestational diabetes
  • Type 1 Diabetes Mellitus
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00652509

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: HealthPartners Investigators/Collaborators
Principal Investigator: Lovelace Clinic Foundation Investigators/Collaborators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00652509     History of Changes
Other Study ID Numbers: 2008_510, MK-0431-111
Study First Received: March 31, 2008
Last Updated: August 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014