PRESSURE CHECK: Find Your Path to Better Health

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06122246
Status
Recruiting
Apply to this trial

Conditions

  • Blood Pressure

Eligibility Criteria

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

Interventions

  • Community Health Worker (CHW) — BEHAVIORAL
    Participants will receive the additional support of a Community Health Worker (CHW); specific activities include: support with home BP monitoring, reminders to attend RBPM clinical visits, and support with social issues impacting health (e.g., food insecurity; transportation; housing instability).
  • Remote Blood Pressure (BP) Management Program (RBPM) — OTHER
    Participants will receive a medical model of remote BP management (RBPM). Care is guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making.

Study Details

This study seeks to develop the evidence for a sustainable, community-partnered, multi-level health system strategy to improve blood pressure control. Two team-based approaches are being tested: 1) a medical model of remote BP management (RBPM) alone, and 2) RBPM plus a social model with a community health worker (CHW). These 2 strategies are being compared with a standard community screening program with referral to primary care.

Key Dates

Start date
Apr 14, 2024
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
1,440 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Remote Blood Pressure (BP) Management Program
    Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a nurse or pharmacist. As part of the RBPM component, participants receive routine clinical care, guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. The duration of the intervention is 6 months, after which they are referred back to their PCP. Enrollment and graduation letters are sent to the PCP and care transitions are coordinated.
  • Experimental: Remote Blood Pressure (BP) Management Program + Community Health Worker (CHW)
    Participants are enrolled in a remote BP management program (RBPM) inclusive of home BP monitoring and telehealth visits with a Pressure Check nurse or pharmacist plus a social model with a CHW. As part of the RBPM component, participants receive routine clinical care, guided by protocols based on ACC/AHA High Blood Pressure Guidelines. This may include medications and/or lifestyle modifications, as is clinically indicated and personalized to each participant using principles of shared decision making. As part of the CHW component, participants receive support with home BP monitoring, reminders to attend RBPM clinical visits, and support with social issues impacting health (e.g., food insecurity; transportation; housing instability). The duration of the intervention is 6 months, after which they are referred back to their PCP. Enrollment and graduation letters are sent to the PCP and care transitions are coordinated.
  • No Intervention: Usual Care
    Participants receive education about hypertension and are referred to primary care for ongoing management. If a participant does not have a PCP, they receive assistance making an appointment with a new PCP.

Primary Outcome Measure

Blood Pressure Control [ Time Frame: 6 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
YaleNew HavenConnecticut06520-
Massachusetts General Brigham HospitalBostonMassachusetts02199-
Houston MethodistHoustonTexas77030-
Sentara HealthNorfolkVirginia23502-

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