Cardiovascular Research Outreach Through Women's Beauty Networks (CROWN)

November 6, 2026 updated by: Johns Hopkins University

CROWN: Cardiovascular Research Outreach Through Women's Beauty Networks

CROWN is a two-arm, cluster-randomized Hybrid Type 2 effectiveness-implementation trial evaluating a multi-level, salon-based cardiovascular intervention among women with uncontrolled blood pressure. The intervention combines stylist-led blood pressure screening in beauty salons, home blood pressure monitoring with remote clinical oversight, community health worker coaching and social needs navigation, and clinical pharmacist medication management support.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

CROWN is a cluster-randomized trial enrolling 16 beauty salons in the Baltimore-Washington Metropolitan Area, randomized 1:1 to the CROWN intervention or enhanced usual care in four staggered cohorts, with a 6-month active intervention period followed by a 6-month maintenance phase. In intervention salons, two stylists per salon are trained and certified as Heart Health Stylists to conduct blood pressure screenings at Heart Health Stations equipped with validated blood pressure devices and interactive educational tablets. Participants enrolled at intervention salons receive a home blood pressure monitor linked to the Luscii/Omron mobile app for remote monitoring. They also receive personalized coaching and social needs navigation from community health workers, and clinical pharmacist review with medication titration recommendations sent to their primary care clinicians. Participants at enhanced usual care salons receive a home blood pressure monitor, basic measurement instruction, and printed educational materials. Eligibility (women aged 18 to 75 years, self-reported hypertension and/or blood pressure ≥130/80 mmHg, regular salon client) will be confirmed through three standardized blood pressure measurements, medical history, medication review, and social needs assessment, conducted in private salon spaces or by phone. Assessments at baseline, 3, and 6 months include standardized blood pressure, weight, point-of-care hemoglobin A1c and lipid panels, and surveys on health behaviors, medication adherence, quality of life, and social needs. Participants will receive and keep their home monitor. Participants without a primary care provider will be linked to partner federally qualified health centers. The primary outcome is change in systolic blood pressure from baseline to 6 months. Secondary outcomes include blood pressure control rates, medication adherence, cardiovascular health behaviors, and social needs resolution. Implementation outcomes (reach, adoption, fidelity, and maintenance at 12 months) will be evaluated using the RE-AIM framework, alongside cost-effectiveness analysis and qualitative interviews with stylists, participants, salon owners, and clinical staff.

Study Type

Interventional

Enrollment (Estimated)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Oluwabunmi Ogungbe, PhD, MPH, RN
  • Phone Number: 4106141519
  • Email: oogungb3@jh.edu

Study Contact Backup

  • Name: Yvonne Commodore-Mensah, PhD, MHS, RN
  • Phone Number: 4106141519
  • Email: ycommod1@jhmi.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women are eligible if:

  • Aged 18 to 75 years
  • Self-reported diagnosis of hypertension and/or blood pressure ≥130/80 mmHg confirmed on repeat measurement
  • Regular client at a participating salon, with at least two visits in the past 6 months
  • Willing to complete follow-up assessments through 6 months

Exclusion Criteria:

Women are excluded if:

  • Pregnant or planning pregnancy during the study period
  • End-stage renal disease
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CROWN Intervention Arm

Women enrolled at salons randomized to the intervention will receive the multi-level CROWN program for 6 months. It includes blood pressure screening and health education by trained Heart Health Stylists, home blood pressure monitoring with remote clinical oversight, community health worker coaching and social needs navigation, and clinical pharmacist medication management support. A 6-month maintenance phase with reduced study support follows.
Behavioral: CROWN Intervention

CROWN includes: 1. Heart Health Stations in each salon with a validated blood pressure device and tablet-based cardiovascular health education. 2. Blood pressure screening by stylists certified through a 7- to 8-week blended training program, with warm handoffs to community health workers. 3. Community health worker coaching, care coordination, and social needs screening and referral through The MEDI platform. 4. Clinical pharmacist review of home blood pressure trends, with medication titration recommendations sent to participants' primary care clinicians. 5. An Omron home blood pressure monitor linked to the Luscii app for remote monitoring with clinical escalation. Participants without a primary care provider are linked to partner federally qualified health centers.
Active Comparator: Enhanced Usual Care Arm

Women enrolled at salons randomized to enhanced usual care will receive in-salon blood pressure screening, a home blood pressure monitor with basic instruction, and printed cardiovascular health education materials. They will not receive community health worker coaching, pharmacist medication support, or care coordination.
Behavioral: Enhanced Usual Care

Enhanced usual care includes: 1. Blood pressure screening at the salon using a validated automated device by stylists who receive basic screening training. 2. An Omron home blood pressure monitor with basic instruction on proper measurement technique. 3. Printed educational handouts on cardiovascular health, medication adherence, and the importance of primary care follow-up. 4. A summary report of home blood pressure readings at study completion, with guidance on sharing results with their health care provider. Research staff will start the clinical escalation protocol for readings in the hypertensive urgency or emergency range. After the 6-month intervention period, salons will be offered CROWN training materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Systolic Blood Pressure
Time Frame: Baseline, 3 months, 6 months

Mean change in systolic blood pressure (mmHg) from baseline to 6 months, compared between CROWN and enhanced usual care arms. Blood pressure is measured with a validated automated device after 5 minutes of seated rest. Three readings are taken 1 minute apart, and the average of the second and third readings is used.
Baseline, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Control
Time Frame: Baseline, 3 months, 6 months

Proportion of participants achieving blood pressure control, defined as systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg, using the standardized measurement protocol.
Baseline, 3 months, 6 months
Change in Diastolic Blood Pressure
Time Frame: Baseline, 3 months, 6 months

Mean change in diastolic blood pressure (mmHg) from baseline, using the standardized measurement protocol.
Baseline, 3 months, 6 months
Change in Hemoglobin A1c
Time Frame: Baseline, 3 months, 6 months

Change in hemoglobin A1c (%) measured by finger-stick point-of-care testing.
Baseline, 3 months, 6 months
Change in Lipid Panel
Time Frame: Baseline, 3 months, 6 months

Change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL) measured by finger-stick point-of-care testing.
Baseline, 3 months, 6 months
Time to Blood Pressure Control
Time Frame: Baseline through 6 months

Time from enrollment to first achievement of blood pressure control (<130/80 mmHg).
Baseline through 6 months
Change in Body Weight and Body Mass Index
Time Frame: Baseline, 3 months, 6 months

Change in body weight (kg) and body mass index (kg/m²) measured with calibrated equipment using standardized protocols.
Baseline, 3 months, 6 months
Change in Medication Adherence
Time Frame: Baseline and 6 months

Measured with the Hill-Bone Compliance to High Blood Pressure Therapy Scale. Scores range from 14 to 56, and higher scores indicate poorer adherence.
Baseline and 6 months
Change in Health-Related Quality of Life
Time Frame: Baseline and 6 months

Measured with the PROMIS-29 Profile. Domain scores are reported as T-scores (mean 50, SD 10). Higher scores indicate more of the domain measured, so higher is better for function domains and worse for symptom domains.
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Oluwabunmi Ogungbe, PhD, MPH, RN, Johns Hopkins School of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2027

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

October 21, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00592583
  • 1R01HL189303-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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