TrialPath
← Back to searchRecruiting

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

NCT07398391 · University of California, San Diego
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Blood Pressure Care for Advancing Real-World Evidence (BPCARE): an RCT of Adherence
About this study
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.
Eligibility 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.
Study design
Enrollment target: 250 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2026-01-09
Estimated completion: 2030-05
Last updated: 2026-02-09
Interventions
Behavioral: BPCARE Intervention
Primary outcomes
  • Medication Adherence Assessed by Self-Report Questionnaire and Unannounced Pill Counts (From baseline/orientation until the end of the follow-up visit at 6 months post randomization)
Sponsor
University of California, San Diego · other
With: Family Health Centers of San Diego, National Heart, Lung, and Blood Institute (NHLBI)
Contacts & investigators
ContactTala Al-Rousan, MD, MPH · contact · talrousan@health.ucsd.edu · 619 356 3227
ContactSabrina Smadi, MS · contact · ssmadi@health.ucsd.edu
All locations (2)
University of California, San DiegoActive Not Recruiting
San Diego, California, United States
Family Health Centers of San DiegoRecruiting
San Diego, California, United States