Peer-Led Self-Management Support in "Real World" Clinical and Community Settings

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 Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Peer-Led Self-Management

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 Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; Other Names: Peer Support; Peer Leadership
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in clinical, self-care and diabetes-related quality of life from baseline	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in clinical, self-care and diabetes-related quality of life from baseline	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.	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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: American Academy of Family Physicians
• Investigators: Principal Investigator: Michele Heisler, MD, MPA, University of Michigan

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 17, 2012
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 25, 2012

Study Record Updates

• Last Update Posted (Estimate): September 9, 2014
• Last Update Submitted That Met QC Criteria: September 8, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: self-management; empowerment; community health worker; peer support; peer leader
• Other Study ID Numbers: DRDA 90-0893