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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517919
• Other study ID #: DRDA 90-0893
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: September 8, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	American Academy of Family Physicians

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No