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

NCT ID: NCT07042386

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-05-31

Brief Summary

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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

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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

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Hypertension

Keywords

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Hypertension Implementation Science Beauty Salon Women Community Based Intervention Cardiovascular Disease Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessors and data analysts will be masked to treatment allocation.

Study Groups

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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.

Group Type EXPERIMENTAL

CROWN Intervention

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oluwabunmi Ogungbe, PhD, MPH, RN

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Nursing

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Central Contacts

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Oluwabunmi Ogungbe, PhD, MPH, RN

Role: CONTACT

Phone: 4106141519

Email: [email protected]

Yvonne Commodore-Mensah, PhD, MHS, RN

Role: CONTACT

Phone: 4106141519

Email: [email protected]

Other Identifiers

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25ISA1453143

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00497859

Identifier Type: -

Identifier Source: org_study_id