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Clinical Trials/NCT03021746
NCT03021746CompletedNot Applicable

Fostering Sustainability Through Diabetes Self-Management Support

University of Michigan1 site in 1 country358 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
358
Locations
1
Primary Endpoint
Change in A1C Blood Glucose level

Study Overview

Brief Summary

To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Detailed Description

To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Have Type 2 diabetes for at least 6 months
  • •Be Black/African American
  • •Be a resident of metro-Detroit, Toledo, or Flint
  • •Be at least 21 years old
  • •Be under the care of a physician for diabetes
  • •Have transportation to attend the program

Exclusion Criteria

  • •Have Type 2 diabetes for less than 6 months
  • •Under 21 years of age
  • •Not under care of physician
  • •Lack of transportation to attend the program

Arms & Interventions

Parish Nurse plus Peer Leader

Experimental

The focus of this approach is for Peer Leaders (PL) to provide Diabetes Self Management Support (DSMS) with the oversight of Parish Nurses (PN). The first component starts with group-based Diabetes Self Management Education (DSME) provided by Certified Diabetes Educators (CDE), co-facilitated by PN and PL and held at the church. PL will also facilitate activities including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit, with oversight of PN. As the study progresses, PL and PN will have progressive leadership responsibilities. Following DSME, participants will be invited to attend 12 months of monthly DSMS support groups led by the PL, with oversight from the PN. This approach allows for PN to provide direct supervision to PL in areas of clinical content, educational methods, and group facilitation and communication skills.

Intervention: Diabetes Self Management Support (DSMS) (Behavioral)

Peer Leader Only

Experimental

This approach will contain the same elements as the PN plus PL approach, except that a PN will not be used. Rather, PL will provide all aspects of DSMS, including behavioral goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. This approach will be delivered in a group setting. DSME will be provided by CDEs and co-facilitated by a PL to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 monthly DSMS groups led by PL. Following the group sessions, participants will transition into a period of ongoing support. During this time, participants and PL will be encouraged to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. If needed, PL may contact the CDE for additional information

Intervention: Diabetes Self Management Support (DSMS) (Behavioral)

Parish Nurse Only

Experimental

The main focus of this approach will contain all of the same elements as the PN plus PL approach, except that PL will not be used. Rather, the PN will provide all aspects of Diabetes Self Management Support (DSMS), including facilitation of goal setting, monthly phone contacts, and preparation for a diabetes-related health care visit. Diabetes Self Management Education (DSME) will be provided by CDEs and co-facilitated by a PN to ensure consistency in the DSME content. Following DSME, participants will be invited to attend 12 months of monthly, DSMS support groups led by the PN. Following support sessions, participants will transition into a period of ongoing support, where the participants and PN will be encouraged to continue to foster DSMS through programs and initiatives that are meaningful to them, utilizing the existing church infrastructure. The PN may answer clinical questions and may contact the CDE for additional information if needed.

Intervention: Diabetes Self Management Support (DSMS) (Behavioral)

Outcomes

Primary Outcomes

Change in A1C Blood Glucose level

Time Frame: During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.

An A1C test is a blood test that reflects one's average blood glucose levels over the previous 3 months.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gretchen Piatt

Assistant Professor

University of Michigan

Study Sites (1)

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