Remote Hypertension Management for Black Patients

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT06527794
Status
Recruiting
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Conditions

  • Uncontrolled Hypertension

Eligibility Criteria

Sex
ALL
Age
21 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • RHYTHM (Remote Hypertension Tracking Help Management) — BEHAVIORAL
    Home blood pressure telemonitoring with remote medication management by a centralized multidisciplinary team led by a pharmacist; and social support, lifestyle education and connection to community resources to address social needs, provided by a community health worker who is embedded with the centralized team and is tightly connected to community resources and partners
  • Enhanced usual care (UC) — BEHAVIORAL
    All participating sites will receive training on appropriate blood pressure measurement and education on guideline-based hypertension therapy. Additionally, participants in usual care will receive a standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home.

Study Details

This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.

Key Dates

Start date
Dec 13, 2024
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
864 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: RHYTHM (Remote Hypertension Tracking Help Management)
    home blood pressure telemonitoring with remote medication management and social support, lifestyle education and connection to community resources to address social needs
  • Experimental: Enhanced usual care (UC)
    standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home

Primary Outcome Measure

Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12 [ Time Frame: Month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Yhenneko Taylor, PhD
[email protected]
704-355-6562
Asha Ganesan
[email protected]
Yhenneko Taylor, PhD (PRINCIPAL_INVESTIGATOR)

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