Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Cardiovascular Research Outreach Through Women's Beauty Networks (CROWN)

6 november 2026 uppdaterad av: Johns Hopkins University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

272

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Oluwabunmi Ogungbe, PhD, MPH, RN
  • Telefonnummer: 4106141519
  • E-post: oogungb3@jh.edu

Studera Kontakt Backup

  • Namn: Yvonne Commodore-Mensah, PhD, MHS, RN
  • Telefonnummer: 4106141519
  • E-post: ycommod1@jhmi.edu

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Aktiv komparator: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Systolic Blood Pressure
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Blood Pressure Control
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Oluwabunmi Ogungbe, PhD, MPH, RN, Johns Hopkins School of Nursing

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 april 2027

Primärt slutförande (Beräknad)

30 juni 2031

Avslutad studie (Beräknad)

30 juni 2031

Studieregistreringsdatum

Först inskickad

21 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

6 november 2026

Första postat (Faktisk)

13 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB00592583
  • 1R01HL189303-01 (U.S.S. NIH-anslag/kontrakt)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera