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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Oluwabunmi Ogungbe, PhD, MPH, RN
- Numero di telefono: 4106141519
- Email: oogungb3@jh.edu
Backup dei contatti dello studio
- Nome: Yvonne Commodore-Mensah, PhD, MHS, RN
- Numero di telefono: 4106141519
- Email: ycommod1@jhmi.edu
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: 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. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Systolic Blood Pressure
Lasso di tempo: 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
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Blood Pressure Control
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Investigatore principale: Oluwabunmi Ogungbe, PhD, MPH, RN, Johns Hopkins School of Nursing
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- IRB00592583
- 1R01HL189303-01 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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