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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL173155-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Family Health Centers of San Diego | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPCARE Intervention Arm | Experimental | Participants in the BPCARE intervention arm will receive a translated educational booklet, a pill box for pill organization, and two intervention sessions focused on medication adherence within month 1 and 2 after randomization. |
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| Standard Care Control Arm | No Intervention | Participants in the control arm will not receive any additional support, but will still be conducting monthly pill counts, at home BP measurements, and in-person follow-up visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPCARE Intervention | Behavioral | Participants randomized to the BPCARE intervention will receive a culturally and linguistically tailored hypertension-education booklet, a pill organizer to support medication adherence, and two structured intervention sessions focused on medication adherence delivered within month 1 and 2 after randomization. These sessions include individualized counseling on blood pressure management, medication adherence strategies, and lifestyle modification. Participants will also receive ongoing follow-up and support from trained Patient Health Navigators (PHNs), including check-ins, problem-solving assistance, and linkage to additional resources as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence Assessed by Self-Report Questionnaire and Unannounced Pill Counts | Test the efficacy of BPCARE in improving antihypertensive medication adherence at 6 months post randomization (primary outcome; via self-report (Hill-Bone Compliance questionnaire), and unannounced pill counts (using video telecommunications)) compared to enhanced usual care. Hypotheses: BPCARE improves antihypertensive medication adherence H1a through H1b increased hypertension and medication adherence knowledge, H1c increased disease risk perceptions and therapeutic interest and motivation, H1d increased self-efficacy and behavioral skills, H1e reduced barriers, H1f long-term persistence (i.e., time to medication self-discontinuation at 6 months post randomization). | From baseline/orientation until the end of the follow-up visit at 6 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure Measured by Connected Blood Pressure Cuff | Test the efficacy of BPCARE in improving systolic blood pressure at 6 months post randomization (secondary outcome via connected BP cuffs) among hypertensive refugees compared to enhanced usual care. H2: More refugees will have controlled BP in the BPCARE group compared to the control group at 6 months post randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tala Al-Rousan, MD, MPH | Contact | 619 356 3227 | talrousan@health.ucsd.edu | |
| Sabrina Smadi, MS | Contact | ssmadi@health.ucsd.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Active, not recruiting | San Diego | California | 92093 | United States | |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| From baseline/orientation until the end of the follow-up visit at 6 months post randomization |
| Family Health Centers of San Diego |
| Recruiting |
| San Diego |
| California |
| 92102 |
| United States |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |