Take the Pressure Off, NYC!

Hypertension Clinical Trial

Official title:

Take the Pressure Off, NYC! Staten Island Barbershop Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04666909
• Other study ID #: 20-00978
• Status: Completed
• Start date: October 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)