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

This study has been completed.
Sponsor:
Collaborator:
American Academy of Family Physicians
Information provided by (Responsible Party):
Rebecca Mase, University of Michigan
ClinicalTrials.gov Identifier:
NCT01517919
First received: January 17, 2012
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: Peer-Led Self-Management

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Enrollment: 241
Study Start Date: January 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Leadership
  • Peer Support
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517919

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48104
Sponsors and Collaborators
University of Michigan
American Academy of Family Physicians
Investigators
Principal Investigator: Michele Heisler, MD, MPA University of Michigan
  More Information

No publications provided

Responsible Party: Rebecca Mase, Michele Heisler, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01517919     History of Changes
Other Study ID Numbers: DRDA 90-0893
Study First Received: January 17, 2012
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
peer support
peer leader
community health worker
empowerment
self-management

ClinicalTrials.gov processed this record on October 29, 2014