A Cardiometabolic Health Program Linked With Clinical-Community Support and Mobile Health Telemonitoring to Reduce Health Disparities

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Johns Hopkins University
Study ID
NCT05321368
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • LINKED-HEARTS Program — BEHAVIORAL
    The intervention arm will include training on home blood pressure monitoring, Sphygmo blood pressure telemonitoring app, Community Health Worker visit for education, counseling on lifestyles modification and Pharmacist to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.

Study Details

The LINKED- HEARTS Program is a multi-level project that intervenes at the practice level by linking home blood pressure monitoring (HBPM) with a telemonitoring platform (Sphygmo). The program incorporates team-based care by including community health workers (CHWs) and pharmacists to improve the outcomes of multiple chronic conditions (reduced blood pressure (BP), lower blood sugar, and improved kidney function). The LINKED-HEARTS Program will recruit a total of 600 adults with uncontrolled hypertension (BP ≥ 140/90 mm Hg) AND either type 2 diabetes or chronic kidney disease (CKD) across 16 community health centers or primary care practices serving high-risk adults. This cluster-randomized trial consists of two arms: (1) enhanced "usual care arm," wherein patients will be provided with Omron 10 series home BP monitors and will be managed by the patients' primary care clinicians as usual; and (2) the "intervention arm" which will integrate HBPM telemonitoring, a CHW intervention and provider-level interventions into the usual clinical care to improve BP control and provide support for self-management of chronic conditions. The study pharmacist will conduct telehealth, use the Sphygmo app and the Pharmacist Patient Care Process to collaborate with other providers to optimize pharmacologic therapy to improve hypertension outcomes and with payors to ensure consistent access to drug therapy.

Key Dates

Start date
Oct 16, 2023
Status verified
Oct 2025
Primary completion
Oct 21, 2026
Completion
Apr 22, 2027

Study Design

Enrollment
425 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: LINKED-HEARTS Program
    Patients in the LINKED-HEARTS Program will be trained to measure their blood pressure with an Omron 10 series device using the Sphygmo telemonitoring app. The physician, pharmacist and Community Health Worker will have access to transmit data. Community Health Workers will provide education on managing blood pressure; reinforce positive blood pressure self-management behaviors; deliver knowledge and skills to promote healthy chronic conditions; assist with linking clinical and administrative services; and link participants with community resources. The study pharmacist will conduct telehealth visits, optimize pharmacologic therapy. The pharmacists will assess and address medication adherence to improve hypertension and diabetes control.
  • No Intervention: Enhanced Usual Care
    Patients in the Enhanced Usual Care Arm, will receive care as usual from their primary care provider and will be trained to measure their blood pressure with an Omron 10 series device. The staff in each participating community health center practice will be trained in blood pressure measurement best practices.

Primary Outcome Measure

Blood Pressure Control as assessed by percentage of participants with controlled Blood Pressure [ Time Frame: 12 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Unity Health CareWashington D.C.District of Columbia20019
Andrew Robie, MD
Johns Hopkins Community PhysiciansBaltimoreMaryland21205
Sarah Rubin
Choptank Community Health SystemsDentonMaryland21629-

Find similar trials in Washington D.C., DC

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Unity Health Care· Washington D.C., DCJohns Hopkins Community Physicians· Baltimore, MDChoptank Community Health Systems· Denton, MD

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