Fostering Sustainability Through Diabetes Self-Management Support
1 other identifier
interventional
358
1 country
1
Brief Summary
To understand the effectiveness of three approaches to address diabetes self-management support compared to enhanced usual care in church-based settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Mar 2016
Longer than P75 for not_applicable diabetes-mellitus
1 active site
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
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 12, 2017
CompletedFirst Posted
Study publicly available on registry
January 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedDecember 16, 2021
December 1, 2021
5.5 years
January 12, 2017
December 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in A1C Blood Glucose level
An A1C test is a blood test that reflects one's average blood glucose levels over the previous 3 months.
During this study, A1c will be measured at five time points; baseline, 6 months, 9 months, 21 months, and 33 months.
Study Arms (3)
Parish Nurse plus Peer Leader
EXPERIMENTALThe 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.
Peer Leader Only
EXPERIMENTALThis 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
Parish Nurse Only
EXPERIMENTALThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gretchen Piatt, MPH, PhD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 12, 2017
First Posted
January 16, 2017
Study Start
March 1, 2016
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
December 16, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share