Peer-Led Self-Management Support in "Real World" Clinical and Community Settings
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 241
- Locations
- 1
- Primary Endpoint
- Changes in clinical, self-care and diabetes-related quality of life from baseline
Study Overview
Brief Summary
This study will systematically evaluate a training program in state-of-the-art behavioral change approaches and facilitation skills for peer leaders and a peer-led diabetes self-management support program designed to be conducted in community and clinic-based settings on an ongoing basis.
Detailed Description
In phase one we will develop and evaluate a theoretically-driven program to train peer leaders to facilitate longer-term empowerment-based interventions that, when led by health care professionals, have been associated with improved diabetes-related health and psychosocial outcomes.1-8 In phase two we will examine the impact of a sustained peer-led, empowerment-based self-management intervention on improving and maintaining diabetes-related health outcomes. We propose to develop and test the training and program simultaneously in two distinct cultural and linguistic communities with which the team already has strong working relationships and a track record of prior work: African-American (AA) adults in a community-based setting (Ypsilanti, Michigan) and Latino adults (Spanish- and English-speaking) in a clinic-based setting (Southwest Detroit). This will allow us to compare and contrast the translations of the training and program in these two different contexts and to better refine and understand effective methods and develop culturally tailored training and program materials in both English and Spanish.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •the study will recruit African Americans and Latinos with type 2 diabetes, - at least 21 years old, and
- •who have a regular health care provider, and
- •will commit to attend the 12 session DSME program.
Exclusion Criteria
- •having physical limitations preventing participation, and
- •other serious health conditions (e.g., terminal cancer),
- •serious psychiatric illness, self-reported excessive alcohol or illicit drug use, and
- •serious diabetes complications (e.g., blindness) that would impede meaningful participation in the program
Arms & Interventions
Intervention: Peer Led Self-Management
Intervention: Peer Led Self-Management (PLSM) involves the DSME program followed by 12 months of peer-led ongoing self-management support
Intervention: Peer-Led Self-Management (Behavioral)
Diabetes Self-Management Education
Control: Diabetes Self-Management Education (DSME) involves 12 sessions of self-management training including diabetes education, one-on-one sessions, bi-weekly phone contacts, and preparation for a clinic visit.
Outcomes
Primary Outcomes
Changes in clinical, self-care and diabetes-related quality of life from baseline
Time Frame: Measured at completion of 12 session DSME program, DSME program completion occurs between 3 and 6 months following enrollment; 6 months post-completion; 12 months post-completion
Clinical, self-care and diabetes-related quality of life improvements including the following measures: A1c, Summary of Diabetes Self-Care Activities Measure, Diabetes Distress Scale (DDS)
Secondary Outcomes
- Changes in clinical, self-care and diabetes-related quality of life from baseline(Measured at completion of 12 session DSME program, DSME program completion occurs between 3 and 6 months following enrollment; 6 months post-completion; 12 months post completion)
Investigators
Rebecca Mase
Michele Heisler, MD
University of Michigan