250 Participants Needed

BPCARE Intervention for High Blood Pressure

(BPCARE Trial)

Recruiting at 1 trial location
TA
SS
Overseen BySabrina Smadi, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Diego
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help refugees with high blood pressure adhere to their medication and better control their condition. The researchers aim to determine if sessions led by community health workers can improve outcomes compared to receiving only information and a blood pressure monitor. Participants will be divided into two groups: one will receive additional support through the BPCARE program (a structured intervention for blood pressure management), while the other will receive standard care. Ideal candidates for this trial are individuals diagnosed with high blood pressure, who speak English as a second language, and reside in San Diego with access to video calls.

As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions for the refugee community.

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it focuses on improving adherence to your current antihypertensive medications.

What prior data suggests that the BPCARE intervention is safe?

Research has shown that working with community health workers (CHWs) is generally safe and can effectively lower blood pressure. In studies, CHWs helped reduce the systolic blood pressure by 4.7 to 13.2 points. This indicates that CHWs play an important role in managing blood pressure outside regular clinics.

Additionally, a review of several studies found that programs supporting adherence to high blood pressure treatment plans significantly improve blood pressure control compared to usual care. This suggests that educational and motivational support, like the BPCARE program, can safely help individuals adhere to their medication plans.

Furthermore, research supports that closely managing blood pressure is safe and aligns with current health guidelines. Overall, the BPCARE approach, which includes education and support from community health workers, appears to be a safe and effective way to manage high blood pressure.12345

Why are researchers excited about this trial?

Researchers are excited about the BPCARE intervention for high blood pressure because it emphasizes medication adherence through practical tools and educational support. Unlike traditional treatments that solely focus on medication, BPCARE provides participants with a translated educational booklet and a pill box to organize their medication, alongside two personalized intervention sessions. This approach targets the common issue of inconsistent medication use by making it easier for participants to manage their treatment, potentially leading to better health outcomes.

What evidence suggests that the BPCARE intervention is effective for improving medication adherence and blood pressure control in refugees with hypertension?

Research has shown that involving community health workers (CHWs) in managing high blood pressure can reduce the systolic blood pressure by 4.7 to 13.2 points. This indicates that CHWs' involvement can lead to a noticeable drop in blood pressure. Studies also suggest that using digital tools, such as home blood pressure monitoring, results in a greater decrease in blood pressure compared to usual care. In this trial, participants in the BPCARE intervention arm will receive support from CHWs and digital devices, which may help individuals take their medication more regularly and better control their blood pressure.13678

Are You a Good Fit for This Trial?

The BPCARE trial is for adult refugees with hypertension who take blood pressure medication, can use video calls like Zoom, and speak English as a second language. They must have had high blood pressure readings in the past year and be likely to stay in San Diego for at least 6 months.

Inclusion Criteria

English is not my first language.
I can sign and understand the consent form and follow study procedures.
I will not move out of San Diego in the next 6 months.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline/Orientation

Participants complete baseline assessments, provide informed consent, and receive training on study procedures

1 visit
1 visit (in-person)

Treatment

Participants receive the BPCARE intervention or standard care, including monthly pill counts and blood pressure monitoring

6 months
Monthly video visits, in-person visits at 3 and 6 months

Follow-up

Participants are monitored for medication adherence and blood pressure control

6 months
2 visits (in-person), monthly video visits

What Are the Treatments Tested in This Trial?

Interventions

  • BPCARE Intervention

Trial Overview

This study tests if a community health worker-led program (BPCARE) helps people stick to their blood pressure meds better than just getting extra info and a home monitor. It includes education, motivational talks, problem-solving sessions, and action planning over nine months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BPCARE Intervention ArmExperimental Treatment1 Intervention
Group II: Standard Care Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Family Health Centers of San Diego

Collaborator

Trials
9
Recruited
15,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Citations

Blood Pressure Care for Advancing Real-World Evidence ...

Test the efficacy of BPCARE in improving systolic blood pressure at 6 months post randomization (secondary outcome via connected BP cuffs) ...

Blood Pressure Control Advancing Refugee Health Equity ...

The study aims to generate data on the efficacy of this intervention in improving long-term adherence and blood pressure control in the understudied and growing ...

Health Care Delivery Interventions for Hypertension ...

CHW involvement in care led to a 4.7 to 13.2 mm Hg reduction in SBP. CHWs were also the most involved in care outside of the clinic, and they ...

Comparative Effectiveness of Pharmacological and Non ...

The target BP achievement was highest with pharmacological therapy (67.8%), followed by the combined (58.9%) and the non-pharmacological (26.4%) ...

Effectiveness of digital health interventions on blood ...

A statistically significant greater reduction in BP is seen in the intervention group, compared with the control group. The data present high heterogeneity.

A Meta‐Analysis of Randomized Clinical Trials - PMC

Interventions involving hypertension STPs significantly reduce systolic and diastolic BP and improve BP control compared to usual care.

Clinician Decisions After Remote Notification of Elevated ...

This cohort study uses data from a randomized clinical trial to assess the range of clinician responses to elevated blood pressure alerts ...

Late-breaking trials explore issues related to BP care, statin ...

“Our data provide reassurance that intensive blood pressure lowering is safe and support current American Heart Association/American Stroke ...