Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women

Официальное название

CROWN: Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women

Обзор

CROWN is a two-arm, cluster-randomized pilot trial testing the feasibility and preliminary efficacy of a salon-based cardiovascular intervention - training stylists as Heart Health Stylists to conduct in-salon blood pressure screenings, home monitoring with telehealth support, community health-worker coaching, and pharmacist-led medication management - among Black and Hispanic women with hypertension.

Подробное описание

CROWN is a six-month, cluster-randomized pilot trial enrolling approximately 12 beauty salons. In intervention salons, trained Heart Health Stylists provide weekly private blood pressure screenings. Participants recruited from the intervention salons will receive a home blood pressure monitor linked to a mobile app, as well as community health worker coaching sessions and pharmacist medication support. Participants in the enhanced usual care salons will receive only printed educational materials and a home blood pressure monitor. Eligibility (age ≥18, self-identified Black or Hispanic, Systolic Blood Pressure (SBP) ≥130/80) will be confirmed via three standardized BP measurements, medical history review, and medication assessment in private salon alcoves or by phone. Assessments at baseline, 12, and 24 weeks include seated blood pressure (BP), weight, point-of-care hemoglobin A1c, and lipid panels, as well as surveys of health behaviors and social needs. Participants will receive gift cards, and retain the home monitor at the end of the study. The primary outcome is the change in systolic blood pressure; secondary outcomes include blood pressure control rates, adherence, lifestyle behaviors, and social needs resolution, with end-of-study qualitative interviews assessing acceptability.

Вмешательства

• Поведенческое CROWN Intervention
  CROWN Intervention includes: 1. Private BP screenings in salon "Heart Health Stations" by trained Heart Health Stylists 2. Free Omron home BP monitor paired with a mobile app for twice-daily telemonitoring 3. In-depth coaching sessions + monthly check-ins with a community health worker 4. Bi-weekly medication review and adherence support by a clinical pharmacist 5. Digital social-needs screening (AHC HRSN) with referral to community resources
• Поведенческое Enhanced Usual Care
  Enhanced Usual Care include: 1. Private BP screenings in salon "Heart Health Stations" by Heart Health Stylists 2. Printed cardiovascular health brochures 3. Free home blood pressure monitor (no app integration) 4. Standard referrals to social and health services

Первичные конечные точки

• Mean change in systolic blood pressure [Срок оценки: Baseline, 3 months, 6 months]

Вторичные конечные точки (5)

• Change in Hemoglobin A1c [Срок оценки: Baseline, 3 months, 6 months]
• Change in weight, measured in pounds [Срок оценки: Baseline, 3 months, 6 months]
• Change in lipids level [Срок оценки: Baseline, 3 months, 6 months]
• Change in Percent Body Fat [Срок оценки: Baseline, 3 months, 6 months]
• Mean change in diastolic blood pressure [Срок оценки: Baseline, 3 months, 6 months]

Критерии участия

Критерии включения

Women are eligible if:

• At least 18 years old
• Self-identify as Black/African American or Hispanic
• Have an average seated systolic blood pressure of 130 mmHg or higher on initial salon screening, and
• Have visited the participating salons at least twice in the past six months.

Критерии исключения

Women are excluded if:

• Pregnant or planning pregnancy during the study period
• Have end-stage renal disease requiring dialysis
• Have serious medical conditions limiting life expectancy to less than 12 months
• Currently participating in other cardiovascular intervention studies
• Have severe cognitive impairment, impeding informed consent
• Unable to operate blood pressure monitoring equipment after training
• Plan to relocate outside the study area within 6 months
• Have documented adverse reactions to blood pressure cuff usage.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Johns Hopkins University — Baltimore

Идентификаторы

NCT: NCT07042386 · IRB00497859 · 25ISA1453143

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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