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

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.

• CROWN Intervention (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 (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

Primary outcomes

• 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 outcomes

• 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).

Other outcomes

• Change in Number of times health-related social resources were accessed [Baseline, 3 months, 6 months]: Social resource utilization assessed by the AHC Health-Related Social Needs (HRSN) digital screening tool
• Change in Health-related quality of life [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.
• Change in Patient activation [Baseline, 6 months]: Assessed via the Patient Activation Measure-13 (PAM-13). Score of 0-100 where higher scores indicate a better outcome
• Change in Medication adherence [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.
• Change in Self-efficacy [Baseline, 6 months]: Assessed using the New Self-Efficacy Scale (Score Range: 1-5; Higher scores are better)
• Implementation fidelity [6 months]: Implementation fidelity will be evaluated through adherence to intervention protocols. Reporting the number of salons that completed the study.
• Implementation fidelity [6 months]: Implementation fidelity will be evaluated through adherence to intervention protocols. Reporting the number of deviations per salon.
• Adoption [6 months]: Adoption will be measured by the proportion of invited salons and stylists who engage with the intervention.
• Program Cost effectiveness [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.

Sex: Female, ages: 18 Years to 79 Years, accepts healthy volunteers

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.

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