NCT07398391

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of California, San Diego · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Detailed description

Blood Pressure Care for Advancing Real-World Evidence (BPCARE) is a randomized controlled study conducted within a federally qualified health center (FQHC) to examine a community health worker-delivered behavioral intervention integrated into routine hypertension care. The study is implemented at Family Health Centers of San Diego (FHCSD), a safety-net healthcare system serving patients with diagnosed hypertension. Uncontrolled blood pressure remains a major contributor to cardiovascular morbidity, particularly among patients who experience challenges such as language discordance, limited resources, and healthcare access difficulties. Team-based care approaches that extend beyond physician-led models are increasingly used in clinical practice to support hypertension management. Non-physician-led behavioral strategies, including interventions delivered by community health workers (CHWs), have demonstrated potential to support medication-taking behaviors by facilitating patient engagement and connection with the healthcare system. Participants complete screening and baseline assessments prior to randomization. Following randomization, participants are considered enrolled and are followed for a total of six months. A total of 250 patients with a diagnosis of hypertension receiving care at FHCSD will be assigned in a 1:1 ratio to either the BPCARE intervention or standard medical care. Study activities include a pre-randomization orientation/baseline visit, in-person follow-up visits at three and six months, and monthly unannounced pill count video visits. During the pre-randomization orientation/baseline visit, participants receive a detailed overview of study procedures, provide informed consent, complete baseline questionnaires, undergo an initial pill count, and receive training on conducting monthly pill counts and measuring blood pressure at home using study-provided devices. Participants assigned to the intervention arm receive structured support from trained community health workers during the first three months of study participation. Community health workers deliver culturally tailored, theory-informed educational and behavioral strategies, including hypertension and medication education, motivational interviewing, problem-solving and action planning, and ongoing medication adherence support.

Conditions

• Hypertension
• High Blood Pressure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-09
• Primary completion: 2029-08-01
• Completion: 2030-05-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

2 sites across 1 country: United States