Blood Pressure Care for Advancing Real-World Evidence (BPCARE)
Recruiting · NCT07398391 · Interventional (participants receive a specific treatment) · Lead sponsor: University of California, San Diego
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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 it is running
2 locations listed across 1 US state.
- University of California, San Diego - San Diego, California, United States
- Family Health Centers of San Diego - San Diego, California, United States