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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Michigan.
Recruitment status was  Active, not recruiting
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: June 17, 2013
Last verified: January 2012

January 17, 2012
June 17, 2013
January 2010
December 2013   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01517919 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Peer-Led Self-Management Support in "Real World" Clinical and Community Settings
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Diabetes
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
  • 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
    Intervention: Behavioral: Peer-Led Self-Management
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
241
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01517919
DRDA 90-0893
No
Rebecca Mase, University of Michigan
University of Michigan
American Academy of Family Physicians
Principal Investigator: Michele Heisler, MD, MPA University of Michigan
University of Michigan
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP