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Blood Pressure Care for Advancing Real-World Evidence (BPCARE)

Blood Pressure Care for Advancing Real-World Evidence (BPCARE): an RCT of Adherence

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills, Phone or video check-ins, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether support from a community health worker helps adult refugees with high blood pressure take their medicines and control their blood pressure. It compares this support with care that includes blood pressure information and a home blood pressure monitor. The study is for people prescribed blood pressure medicine.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have high blood pressure confirmed at screening.
  • Be at least 21 years old.
  • Speak English as a second language.
  • Be able to give written consent and take part in study activities.
  • In the past year, have at least one top blood pressure number of 130 or higher on an automatic clinic monitor, or 140 or higher at home; and/or have missed a blood pressure medicine dose less than two months ago.
  • Plan to stay in San Diego for the next 6 months.
  • Have access to a mobile phone or computer that can make video calls, such as Zoom.

Who can't join

  • Had a heart or blood vessel event, or a hospital stay for unstable angina (chest pain), in the past 3 months.
  • Had heart failure with symptoms in the past 6 months, or a heart pumping measurement below 35%.
  • Are pregnant or plan to become pregnant in the next 7 months.
  • Are in another trial that involves taking medicines that may change blood pressure.
  • Have a condition that the study team believes would greatly limit your ability to understand or follow study steps or count pills. Examples include dementia (problems with memory and thinking) or psychotic disorders (trouble knowing what is real).
  • Have an immediate family member taking part in this trial.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

CA