Johns Hopkins University
Baltimore, Maryland, 21205, United States
Location status: Recruiting
NCT Number: NCT07042386
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.
Interested in participating?
Request Info18 year–79 year
Female
Interventional
Not applicable
Baltimore, Maryland, 21205, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Women are eligible if:
Exclusion criteria
Women are excluded if:
CROWN Intervention includes:
Enhanced Usual Care include:
Time frame: Baseline, 3 months, 6 months
Mean change in systolic blood pressure as assessed by standardized American Heart Association (AHA)-guided automated measurements in the salon and at home (average of three seated readings after 5 minutes' rest).
Time frame: Baseline, 3 months, 6 months
Hemoglobin A1c by finger-stick point of care testing (POCT)
Time frame: Baseline, 3 months, 6 months
Change in weight via calibrated scales
Time frame: Baseline, 3 months, 6 months
Change in lipids level by finger-stick point of care testing (POCT)
Time frame: Baseline, 3 months, 6 months
Change in percent body fat via calibrated scales
Time frame: Baseline, 3 months, 6 months
Mean change in diastolic blood pressure as assessed by standardized American Heart Association (AHA)-guided automated measurements in the salon and at home (average of three seated readings after 5 minutes' rest).
Time frame: Baseline, 3 months, 6 months
Social resource utilization assessed by the AHC Health-Related Social Needs (HRSN) digital screening tool
Time frame: Baseline, 6 months
Measured with the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 instrument. Score ranges from 4-20, where a higher score correlates to better outcome.
Time frame: Baseline, 6 months
Assessed via the Patient Activation Measure-13 (PAM-13). Score of 0-100 where higher scores indicate a better outcome
Time frame: Baseline, 6 months
Measured with the Hill-Bone Medication Adherence Scale. The total score ranges from 14 to 56. 14 is the worse adherence and 56 is the best adherence.
Time frame: Baseline, 6 months
Assessed using the New Self-Efficacy Scale (Score Range: 1-5; Higher scores are better)
Time frame: 6 months
Implementation fidelity will be evaluated through adherence to intervention protocols. Reporting the number of salons that completed the study.
Time frame: 6 months
Implementation fidelity will be evaluated through adherence to intervention protocols. Reporting the number of deviations per salon.
Time frame: 6 months
Adoption will be measured by the proportion of invited salons and stylists who engage with the intervention.
Time frame: 6 months
Program costs, including expenses for stylist training, salon support, Community Health Worker (CHW) time, and technology infrastructure, will be tracked. Incremental Cost-Effectivness Ratio be reported. The ratio is the additional cost of one intervention compared to another, divided by the difference in their health outcomes.
Contact information is provided by the study sponsor or research team.
Oluwabunmi Ogungbe, PhD, MPH, RN
CONTACT
Yvonne Commodore-Mensah, PhD, MHS, RN
CONTACT
Johns Hopkins University
Other
CROWN: Implementation of a Beauty Salon-Based Strategy for Blood Pressure Management Among Women
Acronym: CROWN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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