BPCARE: Community health worker support to improve blood pressure and medication use
Blood Pressure Care for Advancing Real-World Evidence (BPCARE): an RCT of Adherence
This trial will test whether community health workers can help adult refugees with high blood pressure take their medicines and keep their blood pressure under control compared with enhanced usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT07398391 on ClinicalTrials.gov |
What this trial studies
BPCARE is a randomized, controlled program embedded in a federally qualified health center that compares a multi-component behavioral intervention delivered by community health workers to enhanced usual care (hypertension information plus a home blood pressure monitor). About 250 adult patients with diagnosed hypertension receiving care at Family Health Centers of San Diego will be randomized 1:1 and followed for six months. Study activities include baseline screening and orientation, CHW-led contact and support sessions, and in-person or remote follow-up visits to measure medication adherence and blood pressure control and persistence over time. The intervention is designed to integrate into routine clinical care and address language, access, and resource barriers common among refugee patients.
Who should consider this trial
Good fit: Adults (age 21+) who are refugees receiving care at Family Health Centers of San Diego, have a diagnosis of hypertension and are prescribed antihypertensive medication, speak English as a second language, and have access to a phone or computer for video visits.
Not a fit: People with recent major cardiac events, symptomatic or severe heart failure, current pregnancy, those planning to move out of San Diego within six months, or those without access to a phone/computer are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the program could increase medication adherence and improve blood pressure control among refugee patients, reducing their long-term cardiovascular risk.
How similar studies have performed: Previous team-based and community health worker interventions have shown promising but mixed improvements in medication adherence and blood pressure control in underserved populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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, * Have a last least one recorded automated clinic systolic BP reading of at least 130 mmHg within the past year OR at least one home SBP reading of ≥140 mmHg in the last year. AND/OR answer is in range of less than two months to "when was the last time you missed a dose of your hypertension medication?" * Will not move out of San Diego in the next 6 months, and * Have access to a mobile phone or computer with video telecommunication capacity (e.g. Zoom) Exclusion Criteria: * 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 * Major factors judged to be likely to significantly limit comprehension of or adherence to interventions including dementia, psychotic disorders, or affect ability to conduct pill counts * Any immediate family members participating in the trial.
Where this trial is running
San Diego, California and 1 other locations
- University of California, San Diego — San Diego, California, United States (Active_not_recruiting)
- Family Health Centers of San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Tala Al-Rousan, MD, MPH
- Email: talrousan@health.ucsd.edu
- Phone: 619 356 3227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.