Fostering Sustainability Through Diabetes Self-Management Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- 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
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
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
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
Gretchen Piatt
Assistant Professor
University of Michigan
