Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes

Sponsor
University of Alabama at Birmingham
Study ID
NCT07181304
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PROMOTE — BEHAVIORAL
    PROMOTE components includes 1) peer support, 2) remote patient monitoring of blood glucose (RPM), and 3) integration with clinical care. 1. Peer support delivered by community health workers focused on -- assistance in applying diabetes self-management in daily life, emotional and social support, linkage to clinical care, and ongoing, as-needed support. CHWs visits will include: one-on-one in-person visit, then weekly phone calls for 3 months, then monthly calls for 3 months. 2. RPM team will supply the device and supplies to participants. Data is transmitted electronically to the RPM team through broadband connectivity. Protocols have been developed for research projects; participants will be instructed to monitor blood glucose up to four times a day, based on medication regimen. Levels will be monitored 8 a.m. to 5 p.m. M-F. 3. A monthly report of peer support activities and RPM data will be sent to participants' primary care providers.
  • DSMES — BEHAVIORAL
    Diabetes Self-Management Education and Support delivered virtually.

Study Details

This study will include a type 1 hybrid effectiveness implementation study to evaluate the effectiveness of the PROMOTE (peer support plus remote patient monitoring) program among Black adults with uncontrolled type 2 diabetes recruited from local primary care practices in Jefferson County, Alabama. Additionally, a mixed methods evaluation to characterize the contextual factors relevant to implementation of PROMOTE using Practical Robust Implementation Science Model (PRISM) will be conducted.

Key Dates

First listed
Sep 18, 2025
Start date
Aug 15, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PROMOTE
  • Active Comparator: Control

Primary Outcome Measure

Change in Hemoglobin A1c (A1C) [ Time Frame: Baseline, 6-months ]

Central Contacts

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