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

Stroke Clinical Trial

— BP-REACH  

Official title:

BP-REACH: Blood Pressure Disparities Reduction, Equity, and Access Among Safety Net Patients With Cardiovascular Health Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937685
• Other study ID #: 1P50MD017366-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 2026

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: Monica Ayala-Rivera
• Phone: (323) 442-0934
• Email: ayalariv[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Infarction
• Myocardial Infarction
• Stroke

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	Rancho Los Amigos National Rehabilitation Center	Downey	California
United States	LA General Medical Center	Los Angeles	California
United States	Olive View Medical Center	Sylmar	California
United States	Harbor UCLA Medical Center	Torrance	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	University of California, Irvine, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure (SBP) mmHG	Collected by study staff using blood pressure monitor	12 months
Secondary	Life's Essential 8	American Heart Association - survey measure. Score of 0-100, with 100 indicating a perfect score for cardiovascular health	12 months
Secondary	BMI (body mass index)	Height (cm) and weight (kg) collected by study staff, height divided by height indicating percentage of fat on the body	12 months
Secondary	Total cholesterol	Lab collection by study staff	12 months
Secondary	HgbA1c (hemoglobin A1C)	Lab collection by study staff	12 months
Secondary	Diet	Survey - California Health Interview Survey	12 months
Secondary	Physical activities	Survey - Behavioral Risk Factor Surveillance System Survey Questionnaire	12 months
Secondary	Smoking	Survey - PATH wave 1 survey	12 months