Peer-Led Self-Management Support in "Real World" Clinical and Community Settings
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Peer-Led Self-Management Support in "Real World" Clinical and Community Settings|
- 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 ] [ Designated as safety issue: No ]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)
- 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 ] [ Designated as safety issue: No ]Clinical, self-care and diabetes-related quality of life improvements including the following measures: lipid levels, blood pressure reading, height and weight, BMI, and satisfaction with care.
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: 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
Behavioral: Peer-Led Self-Management
The PLSM intervention is designed to improve and sustain participants' self-management and health-related gains associated with type 2 diabetes. The role of peer leaders is to provide support for (1) ongoing self-management efforts (including the 5-step "action-planning" process), (2) psychosocial and emotional adjustment, and (3) linkage to needed health care resources.
PLSM intervention will consist of three main components provided by the Peer Leaders: weekly self-management support sessions; outreach telephone contacts and inbound telephone call from participants.
No Intervention: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517919
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48104|
|Principal Investigator:||Michele Heisler, MD, MPA||University of Michigan|