Clinical trial NCT01517919: Peer-Led Self-Management Support in "Real World" Clinical and Community Settings
Official title: Peer-Led Self-Management Support in "Real World" Clinical and Community Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: peer support
peer leader
community health worker
empowerment
self-management
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: American Academy of Family Physicians
First posted: 2012-01-25
Enrollment: 241
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Changes in clinical, self-care and diabetes-related quality of life from baseline
timeFrame: 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 outcomes:
measure: Changes in clinical, self-care and diabetes-related quality of life from baseline
timeFrame: 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
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Michele Heisler, MD, MPA
role: PRINCIPAL_INVESTIGATOR
References: