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

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT07398391
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Jan 9, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2029
Completion
May 31, 2030

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (2)

FacilityCityStateZIPSite coordinators
Family Health Centers of San DiegoSan DiegoCalifornia92102
Job Godino, PhD
[email protected]
619-515-2344
Cynthia Juarez Nunez, MPH
[email protected]
University of California, San DiegoSan DiegoCalifornia92093-

Find similar trials in San Diego, CA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Family Health Centers of San Diego· San Diego, CAUniversity of California, San Diego· San Diego, CA

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