CROWN: Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Mean change in systolic blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessors and data analysts will be masked to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
CROWN Intervention Arm
Participants will receive in-salon blood pressure screenings by trained stylists, a home blood pressure monitor connected to a telemonitoring app, community health worker coaching, pharmacist medication support, and digital social needs screening with referrals.
干预措施: CROWN Intervention (Behavioral)
Enhanced Usual Care Arm
Participants will receive in-salon blood pressure screenings, a free Omron home monitor, printed cardiovascular health materials, and standard referrals to social and health services, without telemonitoring, coaching, or pharmacist support.
干预措施: Enhanced Usual Care (Behavioral)
结局指标
主要结局
Mean change in systolic blood pressure
时间窗: Baseline, 3 months, 6 months
Mean change in systolic blood pressure as assessed by standardized American Heart Association (AHA)-guided automated measurements in the salon and at home (average of three seated readings after 5 minutes' rest).
次要结局
- Change in Hemoglobin A1c(Baseline, 3 months, 6 months)
- Change in weight, measured in pounds(Baseline, 3 months, 6 months)
- Change in lipids level(Baseline, 3 months, 6 months)
- Change in Percent Body Fat(Baseline, 3 months, 6 months)
- Mean change in diastolic blood pressure(Baseline, 3 months, 6 months)