ClinicalTrials.gg
Not yet recruitingNCT07934394CROWNUpdated Nov 13, 2026

Cardiovascular Research Outreach Through Women's Beauty Networks

An interventional study of CROWN Intervention and Enhanced Usual Care in Hypertension (HTN), sponsored by Johns Hopkins University. Not yet recruiting. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
272
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 50 studies in Hypertension by Johns Hopkins University — 10 open to participants now, 14 under way, none of them phase 3. Hypertension · Johns Hopkins University.

Planned enrollment
14th of 44
272 · median 138
Started
2027
with 1 other
No phase
39 of 50
6 open now
Primary completion
2031-06
later than 13 of 13 live
Registered
49th of 50
by date

Among the 50 studies in Hypertension by Johns Hopkins University, this one is the 14th largest by planned enrollment of the 44 interventional ones that give a count, is one of 2 that started in 2027, is one of 39 with no phase, reaches primary completion later than 13 of the 13 other live ones, and was the 49th registered.

Hypertension

6,118 studies on the registry are indexed under Hypertension; 914 are open to participants now.

Browse Hypertension studies →

Open to participants now

10 of the 50 studies in Hypertension by Johns Hopkins University are open now, in 5 countries. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 10 open studies →

Who these studies take

Of the 562 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (36%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.

This study: 18 Years to 75 Years · female · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 50 studies in Hypertension by Johns Hopkins University, or all of them as a file.
02

Study summary

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.

Read the detailed description

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.

03

Conditions studied

  • Hypertension (HTN)

Browse trials for

Keywords

  • Implementation science
  • Community Health Workers
  • Cardiovascular Health Equity
  • Women's Health
  • Home Blood Pressure Monitoring
  • Beauty Salon
  • Blood Pressure Control
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Women are excluded if:

  • Pregnant or planning pregnancy during the study period
  • End-stage renal disease
  • Have serious medical conditions limiting to less than 12 months
  • Currently participating in other cardiovascular intervention studies
  • Have severe cognitive impairment, impeding
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
272 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: CROWN Intervention

  • Active comparator
    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.

    Behavioral: Enhanced Usual Care

Interventions

  • BehavioralCROWN Intervention

    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.

  • BehavioralEnhanced Usual Care

    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.

06

What researchers measure

Primary outcomes

  1. Change in Systolic Blood Pressure

    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.

    Time frame: Baseline, 3 months, 6 months

Secondary outcomes

  1. Blood Pressure Control

    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.

    Time frame: Baseline, 3 months, 6 months

  2. Change in Diastolic Blood Pressure

    Mean change in diastolic blood pressure (mmHg) from baseline, using the standardized measurement protocol.

    Time frame: Baseline, 3 months, 6 months

  3. Change in Hemoglobin A1c

    Change in hemoglobin A1c (%) measured by finger-stick point-of-care testing.

    Time frame: Baseline, 3 months, 6 months

  4. Change in Lipid Panel

    Change in total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides (mg/dL) measured by finger-stick point-of-care testing.

    Time frame: Baseline, 3 months, 6 months

  5. Time to Blood Pressure Control

    Time from enrollment to first achievement of blood pressure control (\<130/80 mmHg).

    Time frame: Baseline through 6 months

  6. Change in Body Weight and Body Mass Index

    Change in body weight (kg) and body mass index (kg/m²) measured with calibrated equipment using standardized protocols.

    Time frame: Baseline, 3 months, 6 months

  7. Change in Medication Adherence

    Measured with the Hill-Bone Compliance to High Blood Pressure Therapy Scale. Scores range from 14 to 56, and higher scores indicate poorer adherence.

    Time frame: Baseline and 6 months

  8. Change in Health-Related Quality of Life

    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.

    Time frame: Baseline and 6 months

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2027; primary completion for Jun 2031, 50 months later.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 50 months is above that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Nov 13, 2026
StartEst.
Apr 1, 2027
Primary completionEst.
Jun 30, 2031
CompletionEst.
Jun 30, 2031
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07934394
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Apr 1, 2027 (estimated)
Primary completion
Jun 30, 2031 (estimated)
Completion
Jun 30, 2031 (estimated)
Last update
Nov 13, 2026

Study contacts

Oluwabunmi Ogungbe, PhD, MPH, RN
Contact
oogungb3@jh.edu
4106141519
Yvonne Commodore-Mensah, PhD, MHS, RN
Contact
ycommod1@jhmi.edu
4106141519
Oluwabunmi Ogungbe, PhD, MPH, RN
principal investigator · Johns Hopkins School of Nursing

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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