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

March 31, 2008
August 29, 2012
May 2008
March 2010   (final data collection date for primary outcome measure)
Program satisfaction, behavioral and emotional outcomes. [ Time Frame: 3, 6, 9, 12 months after implementation of intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00652509 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Journey for Control of Diabetes Study (0431-111)
Journey for Control of Diabetes Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Type 2 Diabetes Mellitus
  • 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.
  • Behavioral: Individual Education (IE)
    IE - patients receive 2 hours with a nurse educator and 1 hour with a dietitian.
  • Experimental: 1
    IDEA
    Intervention: Behavioral: Interactive Dialogue to Educate and Activate (IDEA)
  • Active Comparator: 2
    IE
    Intervention: Behavioral: Individual Education (IE)
  • No Intervention: 3
    UC: Patients receive no research intervention.
Sperl-Hillen J, Beaton S, Fernandes O, Von Worley A, Vazquez-Benitez G, Parker E, Hanson A, Lavin-Tompkins J, Glasrud P, Davis H, Adams K, Parsons W, Spain CV. Comparative effectiveness of patient education methods for type 2 diabetes: a randomized controlled trial. Arch Intern Med. 2011 Dec 12;171(22):2001-10. doi: 10.1001/archinternmed.2011.507. Epub 2011 Oct 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
621
July 2011
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 Diabetes Mellitus

Exclusion Criteria:

  • Gestational diabetes
  • Type 1 Diabetes Mellitus
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00652509
2008_510, MK-0431-111
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Principal Investigator: HealthPartners Investigators/Collaborators
Principal Investigator: Lovelace Clinic Foundation Investigators/Collaborators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP