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Cardiovascular Research Outreach Through Women's Beauty Networks (CROWN)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Oluwabunmi Ogungbe, PhD, MPH, RN
- Telefoonnummer: 4106141519
- E-mail: oogungb3@jh.edu
Studie Contact Back-up
- Naam: Yvonne Commodore-Mensah, PhD, MHS, RN
- Telefoonnummer: 4106141519
- E-mail: ycommod1@jhmi.edu
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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. |
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. |
|
Actieve vergelijker: 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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Systolic Blood Pressure
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Blood Pressure Control
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Oluwabunmi Ogungbe, PhD, MPH, RN, Johns Hopkins School of Nursing
Studie record data
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
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Eerst geplaatst (Werkelijk)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB00592583
- 1R01HL189303-01 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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