Beauty Salon Program for High Blood Pressure

(CROWN Trial)

OO
YC
Overseen ByYvonne Commodore-Mensah, PhD, MHS, RN
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage high blood pressure in Black and Hispanic women by using beauty salons as health support centers. In one group, salon stylists trained as Heart Health Stylists will provide blood pressure checks and connect participants with telehealth tools, community health workers, and pharmacists for medication advice. This approach is part of the CROWN Intervention. The other group will receive blood pressure checks and educational materials without telehealth or additional coaching. Women who self-identify as Black or Hispanic, have high blood pressure, and visit participating salons regularly may be well-suited for this trial. As an unphased trial, this study presents a unique opportunity to explore innovative community-based health support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this program is safe for participants?

Research shows that using beauty salons to help manage high blood pressure is a novel approach. In this program, salon stylists receive training to check blood pressure and provide support through telehealth, offering healthcare services remotely. Although specific studies on the safety of this method are lacking, the program emphasizes education and behavior rather than medication or medical procedures, making it generally safe and well-tolerated.

The program aims to assist Black and Hispanic women with high blood pressure by teaching them how to monitor and manage their condition. It includes advice from community health workers and pharmacists. Since no new medications are involved, the risk of side effects remains low. The main goal is to encourage lifestyle changes and better management of high blood pressure, which is typically safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the CROWN Intervention for high blood pressure because it combines several innovative approaches that set it apart from traditional methods like medication and lifestyle changes. First, it incorporates in-salon blood pressure screenings conducted by trained stylists, making it more accessible and less clinical. Additionally, the use of a home blood pressure monitor connected to a telemonitoring app allows for real-time tracking and personalized health insights, which is a step beyond usual care. Lastly, the integration of community health worker coaching and pharmacist support offers a more holistic approach to managing blood pressure, addressing both medical and social needs.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research has shown that community programs can help lower blood pressure. A review of 34 studies found that these programs reduced the systolic blood pressure by an average of 7.26 mmHg. Additionally, personal strategies like health coaching have lowered this number by about 3.9 mmHg. This trial will compare two approaches: the CROWN Intervention Arm, which includes blood pressure checks and support in salons, and the Enhanced Usual Care Arm. The CROWN Intervention combines salon screenings, home monitoring, coaching, and pharmacist support to address various aspects of blood pressure care, potentially aiding in the management of high blood pressure in Black and Hispanic women.26789

Who Is on the Research Team?

OO

Oluwabunmi Ogungbe, PhD, MPH, RN

Principal Investigator

Johns Hopkins School of Nursing

Are You a Good Fit for This Trial?

This trial is for Black/African American or Hispanic women at least 18 years old with high blood pressure (130 mmHg or higher). Participants must have visited the participating salons twice in the past six months. It's not for those who can't use blood pressure equipment, plan to move soon, are pregnant, in other heart studies, on dialysis, severely cognitively impaired, or very ill.

Inclusion Criteria

Self-identify as Black/African American or Hispanic
Have an average seated systolic blood pressure of 130 mmHg or higher on initial salon screening
Have visited the participating salons at least twice in the past six months
See 1 more

Exclusion Criteria

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
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person or by phone)

Treatment

Participants receive in-salon blood pressure screenings, home monitoring, community health worker coaching, and pharmacist support

24 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for changes in blood pressure, weight, and other health metrics

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • CROWN Intervention
Trial Overview The CROWN pilot trial tests a salon-based heart health program where stylists screen blood pressure and support home monitoring. The program includes telehealth support from community health workers and pharmacist-led medication management. Women will be randomly assigned to this intervention or enhanced usual care.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: CROWN Intervention ArmExperimental Treatment1 Intervention
Group II: Enhanced Usual Care ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Citations

Beauty Salon Program for High Blood Pressure (CROWN ...CROWN is a two-arm, cluster-randomized pilot trial testing the feasibility and preliminary efficacy of a salon-based cardiovascular intervention - training ...
Comparative Effectiveness of Implementation Strategies for ...Patient-level strategies also resulted in significant systolic BP reductions of −3.9 mmHg (−5.4, −2.3) for health coaching and −2.7 mmHg (−3.6, −1.7) for home ...
Assessing Community-Based interventions effectiveness on ...Meta-analysis results of 34 studies showed that the interventions reduced the mean systolic blood pressure by 7.26 mmHg [5.32–9.2, CI = 95%] and ...
Implementation Strategies to Improve Blood Pressure ...This scientific statement provides information on the implementation strategies to optimize hypertension management and to improve BP control among adults in ...
5.openresearch.nihr.ac.ukopenresearch.nihr.ac.uk/articles/5-78
Randomised controlled effectiveness study...The ISOFITTER study will establish effectiveness of a self-administered, home IE intervention in lowering blood pressure in people with ...
Beauty Salon-Based Blood Pressure Management ...This study aims to help manage high blood pressure among Black and Hispanic women by using an innovative approach in beauty salons.
Implementation of a Beauty Salon-Based Strategy for Blood ...The primary outcome is the change in systolic blood pressure; secondary outcomes include blood pressure control rates, adherence, lifestyle behaviors, and ...
NCT06694805 | A Study to Evaluate the Effectiveness of ...This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who ...
Group-delivered interventions for lowering blood pressure in ...Group-delivered interventions were effective at lowering BP for people with hypertension compared with UC; their feasibility and cost-effectiveness in primary ...
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