Actively Recruiting
Blood Pressure Care for Advancing Real-World Evidence (BPCARE): a Randomized Trial of Behavioral Intervention to Improve Hypertension Medication Adherence and Blood Pressure Control
Led by University of California, San Diego · Updated on 2026-02-09
250
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
F
Family Health Centers of San Diego
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a community health worker-delivered behavioral intervention can improve medication adherence and blood pressure control among adult refugees diagnosed with hypertension who are prescribed antihypertensive medications. The study compares the BPCARE intervention to enhanced usual care, focusing on effects related to medication-taking behaviors, blood pressure control, and persistence over time. The trial is conducted within a federally qualified health center serving patients facing challenges like language barriers and limited healthcare access. Participants are randomly assigned to either the BPCARE intervention or enhanced usual care. Those in the intervention group receive a culturally tailored hypertension education booklet, a pill organizer, and two counseling sessions within the first two months after randomization. These sessions involve education on hypertension, medication adherence, motivational interviewing, problem-solving, and action planning led by trained community health workers. Both groups receive hypertension education and a home blood pressure monitor, while only the intervention group receives ongoing support from Patient Health Navigators. Participants complete baseline assessments, provide informed consent, and are trained to perform monthly pill counts and home blood pressure measurements using provided devices. Follow-up includes in-person visits at three and six months and monthly unannounced video pill counts over a six-month period. Researchers measure medication adherence through self-report questionnaires and pill counts, along with blood pressure changes using connected devices. The study follows participants for six months to assess the impact of the intervention compared to standard care.
CONDITIONS
Brief Title
Blood Pressure Care for Advancing Real-World Evidence (BPCARE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a clinical diagnosis of hypertension determined at screening
- Be at least 21 years of age
- English as a second language
- Able to provide written informed consent and participate in study procedures
- Have at 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 60 mmHg in the last year
- Will not move out of San Diego in the next 6 months
- Have access to a mobile phone or computer with video telecommunication capacity (e.g. Zoom)
You will not qualify if you...
- Cardiovascular event or hospitalization for unstable angina within last 3 months
- Symptomatic heart failure within the past 6 months or left ventricular ejection fraction less than 35%
- Pregnant or planning to become pregnant within the next 7 months
- Current participation in another clinical trial involving blood pressure changing medications
- Conditions likely to limit comprehension or adherence such as dementia, psychotic disorders, or inability to conduct pill counts
- Immediate family members also participating in the trial
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants complete informed consent, baseline questionnaires, initial pill count, and training on conducting monthly pill counts and measuring blood pressure at home.
1 visit (in-person)
Duration - 6 months
Participants randomized to the intervention arm receive two structured behavioral intervention sessions focused on medication adherence during the first two months, plus ongoing support from community health workers. All participants conduct monthly unannounced pill count video visits and take home blood pressure measurements as part of their care.
Monthly video visits and 2 in-person intervention sessions during first 2 months
Duration - 6 months
Participants attend in-person follow-up visits at 3 and 6 months to assess medication adherence and blood pressure control.
2 visits (in-person)
Trial Site Locations
Total: 2 locations
1
University of California, San Diego
San Diego, California, United States, 92093
Active, Not Recruiting
2
Family Health Centers of San Diego
San Diego, California, United States, 92102
Actively Recruiting
Research Team
T
Tala Al-Rousan, MD, MPH
S
Sabrina Smadi, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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