Fostering Sustainability Through Diabetes Self-Management Support

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

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

Official Title
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Fostering Sustainability Through Diabetes Self-Management Support

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Diabetes Self Management Support (DSMS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parish Nurse plus Peer Leader<br>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. | Behavioral: Diabetes Self Management Support (DSMS)<br> <br> |
| Experimental: Peer Leader Only<br>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 | Behavioral: Diabetes Self Management Support (DSMS)<br> <br> |
| Experimental: Parish Nurse Only<br>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. | Behavioral: Diabetes Self Management Support (DSMS)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African-American