NCT01517919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

3.9 years

First QC Date

January 17, 2012

Last Update Submit

September 8, 2014

Conditions

Diabetes

Keywords

peer supportpeer leadercommunity health workerempowermentself-management

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Changes in clinical, self-care and diabetes-related quality of life from baseline

    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

Study Arms (2)

Intervention: Peer Led Self-Management

EXPERIMENTAL

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

Diabetes Self-Management Education

NO INTERVENTION

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.

Interventions

Peer-Led Self-ManagementBEHAVIORAL

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.

Also known as: Peer Leadership, Peer Support
Intervention: Peer Led Self-Management

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Conditions

Diabetes MellitusEmpowerment

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSocial BehaviorBehavior

Study Officials

  • Michele Heisler, MD, MPA

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michele Heisler, MD

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 25, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

US(1)