Reducing Blood Pressure in Patients With High Cardiovascular Risk

NCT ID: NCT05937685

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

546 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-07-31

Brief Summary

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BP-REACH is a study of a team-based (pharmacist and health coach) program for lowering blood pressure for people with a prior stroke or heart attack in the Los Angeles Department of Health Services healthcare system.

The goal of this clinical trial is to test if this team based program is better at helping people reduce their blood pressure than usual care for people with prior heart attack or stroke. The main questions it aims to answer are:

* Do people in the REACH BP program have lower blood pressure at 12 months compared to those getting usual care?
* Do people in the REACH BP program have better Life's Essential 8 scores and patient experience compared to those getting usual care?

Detailed Description

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Hypertension is the leading contributor to preventable death and a major risk factor for recurrent cardiovascular events. To enhance BP control after stroke or myocardial infarction (MI), multilevel interventions are needed that incorporate health system and patient level factors.

BP-REACH aims to test the impact of an intervention on systolic blood pressure (SBP) for individuals with a history of stroke or MI in a randomized controlled trial in the Los Angeles Department of Health Services healthcare system. The primary outcome will be change in systolic blood pressure (SBP) at 12 months.

Hypothesis: Patients randomized to the intervention will achieve \>2.4 mm Hg greater reduction in SBP at 1 year versus those randomized to usual care.

The study population will include participants from the inpatient and outpatient settings in Los Angeles County Department of Health Services health centers. The participants will be randomized in a 1:1 fashion to usual care or intervention, stratified by site, language and cardiovascular event (myocardial infarction, stroke). Outcomes will be collected from all participants at Baseline, 3 month and 12 month timepoints. The primary outcome is SBP.

Participants randomized to the intervention arm will receive additional a home blood pressure monitor, monthly phone calls from a health coach, and medication initiation and titration by a clinical pharmacist. The pharmacist will follow Los Angeles County Department of Health Services expected practices, which align with the ACC/AHA guidelines for blood pressure control and AHA guidelines for Secondary Stroke Prevention.

Conditions

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Myocardial Infarction Hypertension Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

Participants receive the usual care received by patients of the medical center

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Participants follow the intervention protocol, including receiving educational materials, a home blood pressure monitor, coaching calls from BP REACH coaches and medication management from a pharmacist.

Group Type EXPERIMENTAL

BP REACH Intervention

Intervention Type BEHAVIORAL

Educational materials, written and digital. Home blood pressure monitor and self management education from BP REACH coach. Monthly coaching calls from BP REACH coach. Medication management by pharmacist

Interventions

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BP REACH Intervention

Educational materials, written and digital. Home blood pressure monitor and self management education from BP REACH coach. Monthly coaching calls from BP REACH coach. Medication management by pharmacist

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients of LA General Medical Center, Rancho Los Amigos, Olive Medical Center or Harbor-UCLA Medical Center with ischemic stroke, hemorrhagic stroke, or myocardial infarction
* English or Spanish speaking
* Systolic blood pressure (SBP) ≥ 130 mm Hg

Exclusion Criteria

* Age \< 35 years
* SBP \< 130 mm Hg
* Only speaks a language other than English or Spanish
* Cannot provide informed consent due to dementia or aphasia
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Amytis Towfighi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alejandra Casillas, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Amytis Towfighi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Rancho Los Amigos National Rehabilitation Center

Downey, California, United States

Site Status RECRUITING

LA General Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Olive View Medical Center

Sylmar, California, United States

Site Status NOT_YET_RECRUITING

Harbor UCLA Medical Center

Torrance, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica Ayala-Rivera

Role: CONTACT

(323) 442-0934

Facility Contacts

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Monica Ayala-Rivera

Role: primary

(323) 442-0934

Monica Ayala-Rivera

Role: primary

(323) 442-0934

Monica Ayala-Rivera

Role: primary

(323) 442-0934

Monica Ayala-Rivera

Role: primary

(323) 442-0934

Other Identifiers

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1P50MD017366-01

Identifier Type: NIH

Identifier Source: org_study_id

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