Take the Pressure Off, NYC!

NCT04666909 | Completed DMC

• 1 other identifier: 20-00978
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

blood pressure 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.

Also known as: ABPM 7100 Ambulatory Blood Pressure Monitor

Hypertension Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Black men will be recruited for this study which is a group that is often underrepresented in cardiovascular (CVD) risk reduction and in clinical practices
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Under the age of 18
• Does not consent to participate

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Joseph Ravenell, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 14, 2020
• Study Start: October 10, 2020
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: August 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: This data will not be available outside of the study team and our partners
• Access Criteria: The investigator who proposed to use the data.

Locations

US (1)