Recruiting

Heart Health Intervention

Sponsor:

Johns Hopkins University

Code:

NCT07042386

Conditions

Hypertension

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

CROWN Intervention

Enhanced Usual Care

Study Details

Brief 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.

Conditions

Hypertension

Study ID

NCT07042386

Start date

May 29, 2026

Status verified date

Sep, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

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

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 measure

  • Mean change in systolic blood pressure [ Time Frame: Baseline, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Oluwabunmi Ogungbe, PhD, MPH, RN

4106141519oogungb3@jh.edu

Yvonne Commodore-Mensah, PhD, MHS, RN

4106141519ycommod1@jhmi.edu

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Oluwabunmi Ogungbe

410-614-1519oogungb3@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-08.