Recruiting

BPCARE

Sponsor:

UCLA

Code:

NCT07398391

Conditions

Hypertension

High Blood Pressure

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

BPCARE Intervention

Study Details

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:

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

Conditions

Hypertension

High Blood Pressure

Study ID

NCT07398391

Start date

Jan 9, 2026

Status verified date

Jan, 2026

Completion date

May, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Tala Al-Rousan, MD, MPH

619 356 3227talrousan@health.ucsd.edu

Sabrina Smadi, MS

ssmadi@health.ucsd.edu

Locations

Family Health Centers of San Diego

Recruiting

San Diego, California, United States, 92102

Contacts

Job Godino, PhD

619-515-2344jobg@fhcsd.org

Cynthia Juarez Nunez, MPH

cynthiaju@fhcsd.org

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 9, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-09.