MedTrace Logo

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

NCT07398391 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-02-09

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-09
Primary Completion
2029-08-31
Completion
2030-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07398391 on ClinicalTrials.gov