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

NCT07398391 | Recruiting DMC

• 2 other identifiers: DHRC-BPCARE1R01HL173155-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

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:

• 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

Conditions

Hypertension; High Blood Pressure

Keywords

Medication Adherence; Chronic Disease Management; Blood Pressure Self-Management; Federally Qualified Health Center; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• Medication Adherence Assessed by Self-Report Questionnaire and Unannounced Pill Counts

  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 Outcomes (1)

• Change in Systolic Blood Pressure Measured by Connected Blood Pressure Cuff

  From baseline/orientation until the end of the follow-up visit at 6 months post randomization

Study Arms (2)

BPCARE Intervention Arm

EXPERIMENTAL

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

Standard Care Control Arm

NO INTERVENTION

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.

Interventions

BPCARE Intervention BEHAVIORAL

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.

Also known as: BPCARE

BPCARE Intervention Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Family Health Centers of San Diego: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

University of California, San Diego

San Diego, California, 92093, United States

ACTIVE NOT RECRUITING

Family Health Centers of San Diego

San Diego, California, 92102, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Tala Al-Rousan, MD, MPH

CONTACT

619 356 3227; talrousan@health.ucsd.edu

Sabrina Smadi, MS

CONTACT

ssmadi@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Adjunct Professor, Herbert Wertheim School of Public Health & Human Longevity Science

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 9, 2026
• Study Start: January 9, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)