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

ConditionsHypertension High Blood Pressure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorUniversity of California, San Diego

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

250 Participants

are divided into 2 treatment groups

Group A: BPCARE Intervention ArmExperimental treatment 1 intervention

Group B: Standard Care Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

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).

Time frame

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

Secondary outcomes

Change in Systolic Blood Pressure Measured by Connected Blood Pressure Cuff

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.

Time frame

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

Sponsors and contacts

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University of California, San Diego

Lead sponsor

Family Health Centers of San Diego

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)