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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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)

Locations
United States
California
Family Health Centers of San Diego
RECRUITING
San Diego
University of California, San Diego
ACTIVE_NOT_RECRUITING
San Diego
Contact Information
Primary
Tala Al-Rousan, MD, MPH
talrousan@health.ucsd.edu
619 356 3227
Backup
Sabrina Smadi, MS
ssmadi@health.ucsd.edu
Time Frame
Start Date: 2026-01-09
Estimated Completion Date: 2030-05
Participants
Target number of participants: 250
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Family Health Centers of San Diego, National Heart, Lung, and Blood Institute (NHLBI)
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov