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Recruiting NCT05937685

Reducing Blood Pressure in Patients With High Cardiovascular Risk

No phase Interventional Myocardial Infarction Hypertension Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BP REACH Intervention.
Who it may be relevant to
Registry conditions: Myocardial Infarction, Hypertension, Stroke. Basic parameters: from 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Systolic blood pressure (SBP) mmHG [Time frame: 12 months]
Secondary outcome measures (7)
  • Life's Essential 8 [Time frame: 12 months]
  • BMI (body mass index) [Time frame: 12 months]
  • Total cholesterol [Time frame: 12 months]
  • HgbA1c (hemoglobin A1C) [Time frame: 12 months]
  • Diet [Time frame: 12 months]
  • Physical activities [Time frame: 12 months]
  • Smoking [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 4 centers
  • Rancho Los Amigos National Rehabilitation Center — Downey
  • LA General Medical Center — Los Angeles
  • Olive View Medical Center — Sylmar
  • Harbor UCLA Medical Center — Torrance

Identifiers

NCT: NCT05937685 · 1P50MD017366-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗