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| ID | Type | Description | Link |
|---|---|---|---|
| 25ISA1453143 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CROWN Intervention Arm | Experimental | 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. |
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| Enhanced Usual Care Arm | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CROWN Intervention | Behavioral | CROWN Intervention includes:
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in systolic blood pressure | 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). | Baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c | Hemoglobin A1c by finger-stick point of care testing (POCT) | Baseline, 3 months, 6 months |
| Change in weight, measured in pounds | Change in weight via calibrated scales |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of times health-related social resources were accessed | Social resource utilization assessed by the AHC Health-Related Social Needs (HRSN) digital screening tool | Baseline, 3 months, 6 months |
| Change in Health-related quality of life |
Inclusion Criteria:
Women are eligible if:
Exclusion Criteria:
Women are excluded if:
Eligibility is limited to individuals aged 18 years or older, who self-identify as women regardless of sex assigned at birth, and who self-identify as Black/African American or Hispanic.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oluwabunmi Ogungbe, PhD, MPH, RN | Contact | 4106141519 | oogungb3@jh.edu | |
| Yvonne Commodore-Mensah, PhD, MHS, RN | Contact | 4106141519 | ycommod1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oluwabunmi Ogungbe, PhD, MPH, RN | Johns Hopkins School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Outcomes assessors and data analysts will be masked to treatment allocation.
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| Enhanced Usual Care | Behavioral | Enhanced Usual Care include:
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| Baseline, 3 months, 6 months |
| Change in lipids level | Change in lipids level by finger-stick point of care testing (POCT) | Baseline, 3 months, 6 months |
| Change in Percent Body Fat | Change in percent body fat via calibrated scales | Baseline, 3 months, 6 months |
| Mean change in diastolic blood pressure | 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). | Baseline, 3 months, 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.
| Baseline, 6 months |
| Change in Patient activation | Assessed via the Patient Activation Measure-13 (PAM-13). Score of 0-100 where higher scores indicate a better outcome | Baseline, 6 months |
| Change in Medication adherence | 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. | Baseline, 6 months |
| Change in Self-efficacy | Assessed using the New Self-Efficacy Scale (Score Range: 1-5; Higher scores are better) | Baseline, 6 months |
| Implementation fidelity | Implementation fidelity will be evaluated through adherence to intervention protocols. Reporting the number of salons that completed the study. | 6 months |
| Implementation fidelity | Implementation fidelity will be evaluated through adherence to intervention protocols. Reporting the number of deviations per salon. | 6 months |
| Adoption | Adoption will be measured by the proportion of invited salons and stylists who engage with the intervention. | 6 months |
| Program Cost effectiveness | 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. | 6 months |