HypertensionBPCARENCT07398391
Blood Pressure Care for Advancing Real-World Evidence (BPCARE)
A study testing BPCARE Intervention in people with Hypertension and High Blood Pressure, run by University of California, San Diego at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension, High Blood Pressure
- What is being tested?
- BPCARE Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jan 2026to May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sabrina Smadi, MS contact
United States2 sites, 1 recruiting
- Active, not recruiting
University of California, San Diego
San Diego, California, 92093
- Recruiting
Family Health Centers of San Diego
San Diego, California, 92102
Job Godino, PhD, 619-515-2344, jobg@fhcsd.org
Cynthia Juarez Nunez, MPH, cynthiaju@fhcsd.org
About this study
Official title: Blood Pressure Care for Advancing Real-World Evidence (BPCARE): an RCT of Adherence
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:
Read more
- Does participation in the BPCARE intervention improve antihypertensive medication adherence compared to enhanced usual care?
- 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
Read the detailed description
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.
- Conditions
- Hypertension, High Blood Pressure
- Being tested
- BPCARE Intervention
- Keywords
- Medication Adherence, Chronic Disease Management, Blood Pressure Self-Management, Federally Qualified Health Center, Motivational Interviewing
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPCARE InterventionBehavioural
Also called BPCARE
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: BPCARE Intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline/orientation until the end of the follow-up visit at 6 months post randomization
Secondary outcomes (1)
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.
Measured: From baseline/orientation until the end of the follow-up visit at 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start9 Jan 2026
- Primary completionAug 2029 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Family Health Centers of San Diego, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Tala A lRousan, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398391
- Sponsor's protocol ID
- DHRC-BPCARE
- Other IDs
- 1R01HL173155-01A1
- Acronym
- BPCARE
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Care for Advancing Real-World Evidence (BPCARE): an RCT of Adherence
- ClinicalTrials.gov ID
- NCT07398391
- Acronym / sponsor ID
- BPCARE / DHRC-BPCARE
- Conditions
- Hypertension, High Blood Pressure
- Keywords
- Medication Adherence, Chronic Disease Management, Blood Pressure Self-Management, Federally Qualified Health Center, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Family Health Centers of San Diego, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does participation in the BPCARE intervention improve antihypertensive medication adherence compared to enhanced usual care?
- 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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPCARE Intervention Arm | Experimental | Behavioral: BPCARE InterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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?"
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPCARE InterventionAlso: BPCAREParticipants 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. | Behavioural | BPCARE Intervention Arm |
Primary outcome
Medication Adherence Assessed by Self-Report Questionnaire and Unannounced Pill Counts
Time frame: From baseline/orientation until the end of the follow-up visit at 6 months post randomization
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).
1 secondary outcome
Change in Systolic Blood Pressure Measured by Connected Blood Pressure Cuff
Time frame: From baseline/orientation until the end of the follow-up visit at 6 months post randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sabrina Smadi, MS contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BPCARE Intervention in people with Hypertension and High Blood Pressure, run by University of California, San Diego at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tala Al-Rousan, MD, MPH (619 356 3227, talrousan@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence Assessed by Self-Report Questionnaire and Unannounced Pill Counts (time frame: From baseline/orientation until the end of the follow-up visit at 6 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.