Blood Pressure Care for Advancing Real-World Evidence (BPCARE) (BPCARE)

February 4, 2026 updated by: Tala A lRousan, University of California, San Diego

Blood Pressure Care for Advancing Real-World Evidence (BPCARE): an RCT of Adherence

The goal of this randomized clinical trial is to determine whether a community health worker-delivered, multi-component behavioral intervention can improve antihypertensive medication adherence and blood pressure control among adult refugees with hypertension who are prescribed antihypertensive medications.

The main questions it aims to answer are:

  1. Does participation in the BPCARE intervention improve antihypertensive medication adherence compared to enhanced usual care?
  2. Does participation in the BPCARE intervention improve blood pressure control and persistence over time compared to enhanced usual care?

Researchers will compare participants randomized to the BPCARE intervention to those receiving enhanced usual care (hypertension information and a home blood pressure monitor) to determine the effects on medication adherence, blood pressure control, and persistence.

Participants will:

  • Be randomly assigned to either the BPCARE intervention or enhanced usual care
  • Receive hypertension education and a home blood pressure monitor
  • Participate in community health worker-delivered sessions that include hypertension and medication education, motivational interviewing, problem-solving, and action planning (intervention arm only)
  • Complete questionnaires assessing medication adherence and related psychosocial factors
  • Have blood pressure monitored using connected home blood pressure devices
  • Complete pill counts to assess medication adherence over a nine-month follow-up period

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Blood Pressure Care for Advancing Real-World Evidence (BPCARE) is a randomized controlled study conducted within a federally qualified health center (FQHC) to examine a community health worker-delivered behavioral intervention integrated into routine hypertension care. The study is implemented at Family Health Centers of San Diego (FHCSD), a safety-net healthcare system serving patients with diagnosed hypertension.

Uncontrolled blood pressure remains a major contributor to cardiovascular morbidity, particularly among patients who experience challenges such as language discordance, limited resources, and healthcare access difficulties. Team-based care approaches that extend beyond physician-led models are increasingly used in clinical practice to support hypertension management. Non-physician-led behavioral strategies, including interventions delivered by community health workers (CHWs), have demonstrated potential to support medication-taking behaviors by facilitating patient engagement and connection with the healthcare system.

Participants complete screening and baseline assessments prior to randomization. Following randomization, participants are considered enrolled and are followed for a total of six months. A total of 250 patients with a diagnosis of hypertension receiving care at FHCSD will be assigned in a 1:1 ratio to either the BPCARE intervention or standard medical care. Study activities include a pre-randomization orientation/baseline visit, in-person follow-up visits at three and six months, and monthly unannounced pill count video visits.

During the pre-randomization orientation/baseline visit, participants receive a detailed overview of study procedures, provide informed consent, complete baseline questionnaires, undergo an initial pill count, and receive training on conducting monthly pill counts and measuring blood pressure at home using study-provided devices.

Participants assigned to the intervention arm receive structured support from trained community health workers during the first three months of study participation. Community health workers deliver culturally tailored, theory-informed educational and behavioral strategies, including hypertension and medication education, motivational interviewing, problem-solving and action planning, and ongoing medication adherence support.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92102
        • Recruiting
        • Family Health Centers of San Diego
        • Contact:
        • Contact:
      • San Diego, California, United States, 92093
        • Active, not recruiting
        • University of California, San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a clinical diagnosis of hypertension determined at screening,
  • Be at least 21 years of age,
  • English as a second language,
  • Be able to provide written informed consent and participate in study procedures,
  • Have a last least one recorded automated clinic systolic BP reading of at least 130 mmHg within the past year OR at least one home SBP reading of ≥140 mmHg in the last year. AND/OR answer is in range of less than two months to "when was the last time you missed a dose of your hypertension medication?"
  • Will not move out of San Diego in the next 6 months, and
  • Have access to a mobile phone or computer with video telecommunication capacity (e.g. Zoom)

Exclusion Criteria:

  • A cardiovascular event or hospitalization for unstable angina within last 3 months,
  • Symptomatic heart failure within the past 6 months or left ventricular ejection fraction < 35%,
  • Individuals who are pregnant, planning on becoming pregnant within the next 7 months
  • Current participation in another clinical trial that includes taking medications that may change blood pressure, or
  • Major factors judged to be likely to significantly limit comprehension of or adherence to interventions including dementia, psychotic disorders, or affect ability to conduct pill counts
  • Any immediate family members participating in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BPCARE Intervention Arm
Participants in the BPCARE intervention arm will receive a translated educational booklet, a pill box for pill organization, and two intervention sessions focused on medication adherence within month 1 and 2 after randomization.
Behavioral: BPCARE Intervention
Participants randomized to the BPCARE intervention will receive a culturally and linguistically tailored hypertension-education booklet, a pill organizer to support medication adherence, and two structured intervention sessions focused on medication adherence delivered within month 1 and 2 after randomization. These sessions include individualized counseling on blood pressure management, medication adherence strategies, and lifestyle modification. Participants will also receive ongoing follow-up and support from trained Patient Health Navigators (PHNs), including check-ins, problem-solving assistance, and linkage to additional resources as needed.
Other Names:
  • BPCARE
No Intervention: Standard Care Control Arm
Participants in the control arm will not receive any additional support, but will still be conducting monthly pill counts, at home BP measurements, and in-person follow-up visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence Assessed by Self-Report Questionnaire and Unannounced Pill Counts
Time Frame: From baseline/orientation until the end of the follow-up visit at 6 months post randomization
Test the efficacy of BPCARE in improving antihypertensive medication adherence at 6 months post randomization (primary outcome; via self-report (Hill-Bone Compliance questionnaire), and unannounced pill counts (using video telecommunications)) compared to enhanced usual care. Hypotheses: BPCARE improves antihypertensive medication adherence H1a through H1b increased hypertension and medication adherence knowledge, H1c increased disease risk perceptions and therapeutic interest and motivation, H1d increased self-efficacy and behavioral skills, H1e reduced barriers, H1f long-term persistence (i.e., time to medication self-discontinuation at 6 months post randomization).
From baseline/orientation until the end of the follow-up visit at 6 months post randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure Measured by Connected Blood Pressure Cuff
Time Frame: From baseline/orientation until the end of the follow-up visit at 6 months post randomization
Test the efficacy of BPCARE in improving systolic blood pressure at 6 months post randomization (secondary outcome via connected BP cuffs) among hypertensive refugees compared to enhanced usual care. H2: More refugees will have controlled BP in the BPCARE group compared to the control group at 6 months post randomization.
From baseline/orientation until the end of the follow-up visit at 6 months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Family Health Centers of San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

January 27, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DHRC-BPCARE
  • 1R01HL173155-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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