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Not Yet RecruitingNCT07042386

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

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

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
144 (estimated)
Sponsor
Johns Hopkins University · Academic / Other
Sex
Female
Age
18 Years – 79 Years
Healthy volunteers
Accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCROWN InterventionCROWN 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
BEHAVIORALEnhanced Usual CareEnhanced 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

Timeline

Start date
2026-05-01
Primary completion
2028-05-31
Completion
2028-05-31
First posted
2025-06-29
Last updated
2026-04-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07042386. Inclusion in this directory is not an endorsement.