Take the Pressure Off, NYC!

NCT ID: NCT04666909

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

411 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-10

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Briefly, a trained barbershop navigator will work with each barbershop to measure blood pressure on each adult customer who agrees, and to provide culturally-targeted education about high blood pressure and its consequences, and motivational interviewing-informed counseling about therapeutic lifestyle changes. For customers found to have high blood pressure, the navigator will also provide referral and navigation to a medical provider and, as appropriate, a local pharmacy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This program will be patterned after barbershop-based blood pressure programs that have demonstrated efficacy in achieving lower blood pressure and improved hypertension control rates among Black men with high blood pressure. This program will reach 10-12 barbershops per year, working with 2-3 barbershops each quarter. Briefly, a trained barbershop navigator will work with each barbershop t o measure blood pressure on each adult customer who agrees, and to provide culturally-targeted education about high blood pressure and its consequences, and motivational interviewing-informed counseling about therapeutic lifestyle changes. For customers found to have high blood pressure, the navigator will also provide referral and navigation to a medical provider and, as appropriate, a local pharmacy. At all recruitment events, all study team members and potential participants must wear masks and practice social distancing when appropriate. Participants who do not have face masks should be offered masks for continued outreach participation. Study team members will also wear gloves and have hand sanitizer visible. When available, staff should wash hands frequently with soap and water. If this option is not available, staff should frequently use hand sanitizer.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hypertension Group

Participants will receive a free blood pressure screening and receive educational counseling about the importance of maintaining a healthy blood pressure. In addition, educational counseling will be administered in months 3 and 6.

blood pressure

Intervention Type DIAGNOSTIC_TEST

The Welch Allyn ABPM 7100 is an easy-to-use 24-hour ambulatory blood pressure monitor that is designed to help avoid the effects of white coat hypertension, provide accurate sleep blood pressure readings, and tailor drug therapy regimes to your individual patient's needs.

This device is programmed to take three BP readings a minute apart. To be eligible, participants must have an average SBP \> 135 mm Hg or DBP \> 85 mmHg (based on the average of 3 BP readings); or average SBP \> 130 mm Hg or DBP \> 80 mm hg (for those with diabetes or kidney disease) based on JNC-7 criteria for uncontrolled HTN.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood pressure

The Welch Allyn ABPM 7100 is an easy-to-use 24-hour ambulatory blood pressure monitor that is designed to help avoid the effects of white coat hypertension, provide accurate sleep blood pressure readings, and tailor drug therapy regimes to your individual patient's needs.

This device is programmed to take three BP readings a minute apart. To be eligible, participants must have an average SBP \> 135 mm Hg or DBP \> 85 mmHg (based on the average of 3 BP readings); or average SBP \> 130 mm Hg or DBP \> 80 mm hg (for those with diabetes or kidney disease) based on JNC-7 criteria for uncontrolled HTN.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABPM 7100 Ambulatory Blood Pressure Monitor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants must be age 18 years or older
* Self-identified as a black or African American male
* Have uncontrolled hypertension defined as SBP\>135 mmHg or DBP\>85 mmHg and SBP \>130 mmHg or DBP \>80 mmHg (in those with diabetes) at the screening

Exclusion Criteria

* Under the age of 18
* Does not consent to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph Ravenell, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NYU Langone Health

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-00978

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prehypertension Labeling
NCT01434953 TERMINATED NA
Cut Your Blood Pressure 3
NCT03726710 COMPLETED NA
We Talk About Our Hypertension
NCT02483780 COMPLETED NA