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Clinical Trials/NCT02066155
NCT02066155
Completed
Not Applicable

Ongoing Diabetes Self-Management Support in Church-Based Settings

University of Michigan1 site in 1 country94 target enrollmentJanuary 2013
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
University of Michigan
Enrollment
94
Locations
1
Primary Endpoint
Hemoglobin A1C
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

African Americans are twice as likely to have diabetes compared to their White counterparts and experience higher rates of diabetes-related complications. Diabetes-related health disparities underscore the need for effective, culturally tailored approaches to promote and sustain diabetes self-management over time. Diabetes self-management education (DSME) is effective in improving diabetes outcomes in the short-term. However, many adults with diabetes cannot sustain achieved improvements without continued follow-up and support. The 2012 revisions of both the National Standards for Diabetes Care 6 and the National Standards for DSME and Support emphasize the importance of providing both initial DSME and on-going diabetes self-management support (DSMS) to assist people with diabetes in maintaining effective self-management throughout a lifetime. While a great deal is understood about how to provide effective, initial DSME, less is known about who, where, when, and how to provide effective, sustained DSMS. One significant challenge is that DSME is a covered benefit in the healthcare system, while DSMS is not. This ultimately limits access and availability of DSMS programs, especially for low-income African Americans. Accordingly, there is critical need to develop, evaluate, and understand effective DSMS models that are ongoing, patient-driven, and embedded in the community.

Detailed Description

The long-term goal of our research is to determine the most effective, practical, and sustainable approaches to provide ongoing DSMS in the context of the communities in which people live. In the African American community, the church plays a central role in community life and can serve as a powerful channel to deliver health promotion programs. Churches in the community are thus ideal venues to intervene to help people with diabetes achieve their self-management related goals. The objective of this proposal is to examine the relative effectiveness of three approaches to address DSMS compared to enhanced usual care within the context of the church-based setting. To accomplish this objective, a cluster randomized, modified stepped wedge, practical behavioral trial with three parallel DSMS approaches will be implemented. Twenty-one African American churches (23 African American participants per church) in metro-Detroit will be randomized to one of three DSMS approaches. Fourteen parish nurses who are volunteers at the churches, and 21 peer leaders will be trained to deliver DSMS. Measures will be collected at baseline, 6, 9, 15 and 27-month follow-up. The primary outcome will be changes in A1c at 9, 15 and 27-month follow-up. Secondary outcomes include changes in weight, blood pressure, quality of life, and diabetes related distress at 9,15 and 27-month follow-up. We hypothesize that 1) participants in both Parish Nurse DSMS and Peer Leader DSMS will have improved outcomes over enhanced usual care, and that 2) participants in Parish Nurse + Peer Leader DSMS will sustain improvements in outcomes achieved following DSME at significantly higher levels than participants in Parish Nurse DSMS and Peer Leader DSMS

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
December 31, 2016
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gretchen Piatt

Assistant Professor

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hemoglobin A1C

Time Frame: Baseline, 3, 9, 15, 27 months

Measure of long-term glucose control

Secondary Outcomes

  • BMI(Baseline, 3, 9, 15, 27 months)

Study Sites (1)

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