Blood Pressure Care for Advancing Real-World Evidence (BPCARE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of California, San Diego
About this trial
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
Eligibility criteria
Qualifiers
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,
Disqualifiers
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
Trial design
Treatments tested in this trial
- BPCARE Intervention
Treatment groups
250 Participants
are divided into 2 treatment groupsLocations
2Family Health Centers of San Diego92102, San DiegoCalifornia, United States
University of California, San Diego92093, San DiegoCalifornia, United States
Sponsors and collaborators
University of California, San Diego
Lead sponsor
Family Health Centers of San Diego
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov