Ongoing Diabetes Self-Management Support in Church-Based Settings

August 5, 2019 updated by: Gretchen Piatt, University of Michigan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for Parish Nurses

  • Registered nurse in Michigan
  • Identified as a parish nurse in the participating church
  • Member of the Detroit Parish Nurse Network
  • Willing to serve as a parish nurse for the research study

Inclusion Criteria for Peer Leaders

  • Have diabetes ≥ one year

  • Be a resident of metro-Detroit

    -≥21 years old and ≥ 8th grade education

  • Have transportation to attend training
  • Be willing to commit to 3 months of training
  • Actively working on his/her own self management goals and
  • Willing to serve as a peer leader

Inclusion Criteria for Participants

  • Have diabetes ≥ 6 months

  • Resident of metro-Detroit

    -≥ 21years old

  • Be under the care of a physician for diabetes
  • Have transportation to attend the program
  • Be a member or regularly attend the participating church

Exclusion Criteria for Parish Nurses

  • Not a registered nurse
  • Not a parish nurse in the church
  • Not a member of the DPNN
  • Unwilling to serve as a parish nurse for the research studyExclusion Criteria for Participants:
  • Non ambulatory or serious health conditions or psychiatric illness (severity requiring hospitalization)
  • Serious diabetes complications (e.g. blindness) that would impede meaningful participation

Exclusion Criteria for Peer Leaders and Participants:

  • Non ambulatory or serious health conditions or psychiatric illness (severity requiring hospitalization)
  • Serious diabetes complications (e.g. blindness) that would impede meaningful participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parish nurse
On-going support provided by parish nurse
Behavioral: Parish nurse
On-going support following diabetes self-management education provided by Parish Nurse
Experimental: Peer support
On-going support provided by a person with diabetes
Behavioral: Peer Support
On-going support following diabetes self-management education provided by a trained person with diabetes
No Intervention: Control group
No on-going support provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1C
Time Frame: Baseline, 3, 9, 15, 27 months
Measure of long-term glucose control
Baseline, 3, 9, 15, 27 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: Baseline, 3, 9, 15, 27 months
Measure of weight loss
Baseline, 3, 9, 15, 27 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes-related distress
Time Frame: Baseline, 3, 9, 15, 27 months
Measure of psychological distress caused by diabetes
Baseline, 3, 9, 15, 27 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Gretchen A Piatt, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

February 16, 2014

First Submitted That Met QC Criteria

February 16, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-PAF00455 PAF
  • DSMS (Other Grant/Funding Number: Bristol-Myers Squibb Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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