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Recruiting NCT07042386

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

No phase Interventional Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CROWN Intervention, Enhanced Usual Care.
Who it may be relevant to
Registry conditions: Hypertension. Basic parameters: 18 years — 79 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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
  • Behavioral 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

Primary outcome measures

  • Mean change in systolic blood pressure [Time frame: Baseline, 3 months, 6 months]
Secondary outcome measures (5)
  • Change in Hemoglobin A1c [Time frame: Baseline, 3 months, 6 months]
  • Change in weight, measured in pounds [Time frame: Baseline, 3 months, 6 months]
  • Change in lipids level [Time frame: Baseline, 3 months, 6 months]
  • Change in Percent Body Fat [Time frame: Baseline, 3 months, 6 months]
  • Mean change in diastolic blood pressure [Time frame: Baseline, 3 months, 6 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Johns Hopkins University — Baltimore

Identifiers

NCT: NCT07042386 · IRB00497859 · 25ISA1453143

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗