Hypertension
Conditions
Keywords
Hypertension, Implementation Science, Beauty Salon, Women, Community Based Intervention, Cardiovascular Disease Prevention
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.
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
BEHAVIORALCROWN 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
BEHAVIORALEnhanced 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
Sponsors
Johns Hopkins University
American Heart Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessors and data analysts will be masked to treatment allocation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in systolic blood pressure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | Baseline, 3 months, 6 months | Hemoglobin A1c by finger-stick point of care testing (POCT) |
| Change in weight, measured in pounds | Baseline, 3 months, 6 months | Change in weight via calibrated scales |
| Change in lipids level | Baseline, 3 months, 6 months | Change in lipids level by finger-stick point of care testing (POCT) |
| Change in Percent Body Fat | Baseline, 3 months, 6 months | Change in percent body fat via calibrated scales |
| Mean change in diastolic blood pressure | 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). |
Countries
United States
Contacts
CONTACTOluwabunmi Ogungbe, PhD, MPH, RN
CONTACTYvonne Commodore-Mensah, PhD, MHS, RN
PRINCIPAL_INVESTIGATOROluwabunmi Ogungbe, PhD, MPH, RN
Johns Hopkins School of Nursing
Outcome results
None listed