Take the Pressure Off, NYC!

Take the Pressure Off, NYC! Staten Island Barbershop Initiative

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Diagnostic test: blood pressure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

This study is limited to men. Because the goal of this study is to reduce the racial disparities in hypertension-related outcomes between minority ethnic/racial groups and whites, the participants in this study will be self-identified as African American or Black

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Diagnostic test: 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.; Other Names: ABPM 7100 Ambulatory Blood Pressure Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Pressure over 6 months	Blood pressure will be measured with FDA approved blood pressure monitor on the first day of the study, 3 months and 6 months after the initial study day.	Initial Study Day 1, Follow up 1 (Day 90 +/- 10), Follow up 2 ((Day 180+/-10)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Joseph Ravenell, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 20-00978

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: This data will not be available outside of the study team and our partners
• IPD Sharing Access Criteria: The investigator who proposed to use the data.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No