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

Johns Hopkins University

Status: Begins enrollment this month

Conditions: Hypertension

Treatments: Behavioral: CROWN Intervention; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07042386

25ISA1453143 (Other Grant/Funding Number)

IRB00497859

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups

CROWN Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: CROWN Intervention

Enhanced Usual Care Arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care