250 Participants Needed

BPCARE Intervention for High Blood Pressure

(BPCARE Trial)

Recruiting at 1 trial location
TA
SS
Overseen BySabrina Smadi, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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

Are You a Good Fit for This Trial?

The BPCARE trial is for adult refugees with hypertension who take blood pressure medication, can use video calls like Zoom, and speak English as a second language. They must have had high blood pressure readings in the past year and be likely to stay in San Diego for at least 6 months.

Inclusion Criteria

English is not my first language.
I can sign and understand the consent form and follow study procedures.
I will not move out of San Diego in the next 6 months.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline/Orientation

Participants complete baseline assessments, provide informed consent, and receive training on study procedures

1 visit
1 visit (in-person)

Treatment

Participants receive the BPCARE intervention or standard care, including monthly pill counts and blood pressure monitoring

6 months
Monthly video visits, in-person visits at 3 and 6 months

Follow-up

Participants are monitored for medication adherence and blood pressure control

6 months
2 visits (in-person), monthly video visits

What Are the Treatments Tested in This Trial?

Interventions

  • BPCARE Intervention

Trial Overview

This study tests if a community health worker-led program (BPCARE) helps people stick to their blood pressure meds better than just getting extra info and a home monitor. It includes education, motivational talks, problem-solving sessions, and action planning over nine months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BPCARE Intervention ArmExperimental Treatment1 Intervention
Group II: Standard Care Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Family Health Centers of San Diego

Collaborator

Trials
9
Recruited
15,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+