Peer-Led Self-Management Support in "Real World" Clinical and Community Settings
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|ClinicalTrials.gov Identifier: NCT01517919|
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : September 9, 2014
|Condition or disease||Intervention/treatment|
|Diabetes||Behavioral: Peer-Led Self-Management|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||241 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Peer-Led Self-Management Support in "Real World" Clinical and Community Settings|
|Study Start Date :||January 2010|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
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.
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.
- 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 ]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)
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517919
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48104|
|Principal Investigator:||Michele Heisler, MD, MPA||University of Michigan|