Empowering Faith-based Communities to Provide Personalized Diabetes Self-management Education and Support (DSMES) in the Magic City
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT07556354
- Status
- Not Yet Recruiting
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Conditions
- BMI
- Blood Cholesterol
- Blood Pressure Monitoring
- Diabetes (DM)
- Diabetes Education
- Weight Change
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Remote Patient Monitoring in a Faith-Based Program — BEHAVIORALParticipants will be randomly-assigned to one of two cohorts. One cohort will participate in a faith-based DSMES program and use remote patient monitoring (RPM) to track their health throughout the duration. Remote patient monitoring allows a participant's healthcare team to visualize and monitor health data outside of scheduled DSMES sessions. These participants will be given blood pressure and blood glucose tracking devices that utilize Bluetooth to automatically upload their health data into an RPM platform, Prevounce, once measurements are taken.
- Traditional Cohort Faith-based DSMES program — BEHAVIORALThe Traditional Cohort will also participate in the DSMES program but instead will be provided traditional blood pressure cuffs and glucometers that will not upload their data to a mobile platform to track their health data. These participants will use traditional means (paper trackers) to track their health data and will provide health updates during scheduled communication with community health workers.
Study Details
In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Active Comparator: Traditional CohortUtilizes paper trackers to track blood glucose and blood pressure readings outside of DSMES sessions
- Experimental: Remote Patient Monitoring (RPM) CohortUtilizes remote patient monitoring platform to track blood pressure and blood glucose readings outside of DSMES sessions
Primary Outcome Measure
Change from Baseline in HbA1C results at 12 weeks [ Time Frame: From enrollment to end of treatment at 12 weeks ]
Central Contacts
- Dashauna Ballard, PhD205-934-6553
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| New Hope Baptist Church | Birmingham | Alabama | 35211 | Sabrina Famuyiwa, MPH Dashauna Ballard, PhD (PRINCIPAL_INVESTIGATOR) Bertha Hidalgo, PhD (PRINCIPAL_INVESTIGATOR) |
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