Reducing Blood Pressure in Patients With High Cardiovascular Risk
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: BP REACH Intervention.
- Кому может быть актуально
- Состояния в реестре: Myocardial Infarction, Hypertension, Stroke. Базовые параметры: от 35 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
BP-REACH: Blood Pressure Disparities Reduction, Equity, and Access Among Safety Net Patients With Cardiovascular Health Risk
Обзор
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?
Подробное описание
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.
Вмешательства
- Поведенческое 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
Первичные конечные точки
- Systolic blood pressure (SBP) mmHG [Срок оценки: 12 months]
Вторичные конечные точки (7)
- Life's Essential 8 [Срок оценки: 12 months]
- BMI (body mass index) [Срок оценки: 12 months]
- Total cholesterol [Срок оценки: 12 months]
- HgbA1c (hemoglobin A1C) [Срок оценки: 12 months]
- Diet [Срок оценки: 12 months]
- Physical activities [Срок оценки: 12 months]
- Smoking [Срок оценки: 12 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
США · 4 центра
- Rancho Los Amigos National Rehabilitation Center — Downey
- LA General Medical Center — Los Angeles
- Olive View Medical Center — Sylmar
- Harbor UCLA Medical Center — Torrance
Идентификаторы
NCT: NCT05937685 · 1P50MD017366-01