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Reducing Blood Pressure in Patients With High Cardiovascular Risk in the Safety-Net (BP-REACH)

Primary Purpose

Myocardial Infarction, Hypertension, Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BP REACH Intervention
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring stroke, myocardial infarction, hypertension, self-management

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rancho Los Amigos National Rehabilitation Center
  • LA General Medical Center
  • Olive View Medical Center
  • Harbor UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Systolic blood pressure
Collected by study staff using blood pressure monitor

Secondary Outcome Measures

Life's Essential 8
American Heart Association - survey measure
BMI
Height and weight collected by study staff
Total cholesterol
Lab collection by study staff
HgbA1c
Lab collection by study staff
Diet
Survey - California Health Interview Survey
Physical activities
Survey - Behavioral Risk Factor Surveillance System Survey Questionnaire
Smoking
Survey - PATH wave 1 survey

Full Information

First Posted
June 30, 2023
Last Updated
June 30, 2023
Sponsor
University of Southern California
Collaborators
University of California, Los Angeles, University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05937685
Brief Title
Reducing Blood Pressure in Patients With High Cardiovascular Risk in the Safety-Net
Acronym
BP-REACH
Official Title
BP-REACH: Blood Pressure Disparities Reduction, Equity, and Access Among Safety Net Patients With Cardiovascular Health Risk
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
University of California, Los Angeles, University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 public 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? Half the participants will be randomly assigned to usual care and half will be assigned to the program. Those assigned to the program will receive a blood pressure cuff to check their blood pressure at home, educational materials, monthly phone calls from a health coach and regular follow up with a pharmacist who will prescribe medications, adjust them, and answer any questions and concerns. The health coach will teach the participants how to log on to the patient portal and access educational materials on an app. Those assigned to usual care will continue seeing their providers. All participants will be asked survey questions once they enroll, at 3 months and at 12 months.
Detailed Description
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, patient, and community 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 public healthcare system. The primary outcome will be change in 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Hypertension, Stroke
Keywords
stroke, myocardial infarction, hypertension, self-management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants receive the usual care received by patients of the medical center
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BP REACH Intervention
Intervention Description
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
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Collected by study staff using blood pressure monitor
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Life's Essential 8
Description
American Heart Association - survey measure
Time Frame
12 months
Title
BMI
Description
Height and weight collected by study staff
Time Frame
12 months
Title
Total cholesterol
Description
Lab collection by study staff
Time Frame
12 months
Title
HgbA1c
Description
Lab collection by study staff
Time Frame
12 months
Title
Diet
Description
Survey - California Health Interview Survey
Time Frame
12 months
Title
Physical activities
Description
Survey - Behavioral Risk Factor Surveillance System Survey Questionnaire
Time Frame
12 months
Title
Smoking
Description
Survey - PATH wave 1 survey
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Ayala-Rivera
Phone
(323) 442-0934
Email
ayalariv@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandra Casillas, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amytis Towfighi, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rancho Los Amigos National Rehabilitation Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Ayala-Rivera
Phone
323-442-0934
Email
ayalariv@usc.edu
First Name & Middle Initial & Last Name & Degree
Antonio Moya, MD
Facility Name
LA General Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Ayala-Rivera
Phone
323-442-0934
Email
ayalariv@usc.edu
First Name & Middle Initial & Last Name & Degree
Grace Kuo, MD
First Name & Middle Initial & Last Name & Degree
Hossein Bahrami, MD
Facility Name
Olive View Medical Center
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Ayala-Rivera
Phone
323-442-0934
Email
ayalariv@usc.edu
First Name & Middle Initial & Last Name & Degree
Neal Rao, MD
First Name & Middle Initial & Last Name & Degree
Anthony Koppula, MD
Facility Name
Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Ayala-Rivera
Phone
323-442-0934
Email
ayalariv@usc.edu
First Name & Middle Initial & Last Name & Degree
Kassi Kronfeld, MD
First Name & Middle Initial & Last Name & Degree
William French, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Blood Pressure in Patients With High Cardiovascular Risk in the Safety-Net

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