Journey for Control of Diabetes Study (0431-111)

NCT00652509 | Completed

• 2 other identifiers: 0431-1112008_510
• Study Type: interventional
• Target: 621
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Program satisfaction, behavioral and emotional outcomes.

  3, 6, 9, 12 months after implementation of intervention

Secondary Outcomes (1)

• Blood sugar level, blood pressure, lipids, cost, comorbidities.

  6, 12, 18, 24, 36, and 48 months after intervention

Study Arms (3)

1

EXPERIMENTAL

IDEA

Behavioral: Interactive Dialogue to Educate and Activate (IDEA)

2

ACTIVE COMPARATOR

IE

Behavioral: Individual Education (IE)

3

NO INTERVENTION

UC: Patients receive no research intervention.

Interventions

Interactive Dialogue to Educate and Activate (IDEA) BEHAVIORAL

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.

1

Individual Education (IE) BEHAVIORAL

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

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes Mellitus

You may not qualify if:

• Gestational diabetes
• Type 1 Diabetes Mellitus

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21986350 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2011
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share