Reducing Blood Pressure in Patients With High Cardiovascular Risk
- Conditions
- Myocardial InfarctionStrokeHypertension
- Interventions
- Behavioral: BP REACH Intervention
- Registration Number
- NCT05937685
- Lead Sponsor
- University of Southern California
- 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 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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 546
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention BP REACH 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.
- Primary Outcome Measures
Name Time Method Systolic blood pressure (SBP) mmHG 12 months Collected by study staff using blood pressure monitor
- Secondary Outcome Measures
Name Time Method BMI (body mass index) 12 months Height (cm) and weight (kg) collected by study staff, height divided by height indicating percentage of fat on the body
Diet 12 months Survey - California Health Interview Survey
Life's Essential 8 12 months American Heart Association - survey measure. Score of 0-100, with 100 indicating a perfect score for cardiovascular health
HgbA1c (hemoglobin A1C) 12 months Lab collection by study staff
Smoking 12 months Survey - PATH wave 1 survey
Total cholesterol 12 months Lab collection by study staff
Physical activities 12 months Survey - Behavioral Risk Factor Surveillance System Survey Questionnaire
Trial Locations
- Locations (4)
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, United States