Recruiting

Observational Study

Sponsor:

Yale University

Code:

NCT06122246

Conditions

Blood Pressure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Community Health Worker (CHW)

Remote Blood Pressure (BP) Management Program (RBPM)

Study Details

Brief summary:

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.

Conditions

Blood Pressure

Study ID

NCT06122246

Start date

Apr 14, 2024

Status verified date

Mar, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Elevated BP, defined as an average resting BP of >=135/85 mmHg based on 3 consecutive blood pressure readings

Exclusion Criteria:

  • People who are pregnant or who plan to become pregnant in the next 6 months at study entry
  • Those that have end stage renal disease on dialysis
  • People receiving active chemotherapy

Study Design

Enrollment

1440 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Community Health Worker (CHW)

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)

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.

Primary outcome measure

  • Blood Pressure Control [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Yale

Recruiting

New Haven, Connecticut, United States, 06520

Sentara Health

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Yale University

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

  • hypertension
  • remote patient monitoring
  • community health worker
  • digital health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-03-24.