HypertensionNCT04666909
Take the Pressure Off, NYC!
An observational study of Hypertension, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- blood pressure
- How many people
- 411 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Under the age of 18
- Does not consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood pressureDiagnostic test
Also called ABPM 7100 Ambulatory Blood Pressure Monitor
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial Study Day 1, Follow up 1 (Day 90 +/- 10), Follow up 2 ((Day 180+/-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start10 Oct 2020
- Primary completion30 Jun 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Ravenell, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666909
- Sponsor's protocol ID
- 20-00978
- Status last verified
- Aug 2022
- First submitted
- 8 Dec 2020
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take the Pressure Off, NYC! Staten Island Barbershop Initiative
- ClinicalTrials.gov ID
- NCT04666909
- Acronym / sponsor ID
- 20-00978
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertension Group | – | Diagnostic Test: blood pressureParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Under the age of 18
- Does not consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood pressureAlso: ABPM 7100 Ambulatory Blood Pressure MonitorThe 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. | Diagnostic test | Hypertension Group |
Primary outcome
Change in Blood Pressure over 6 months
Time frame: Initial Study Day 1, Follow up 1 (Day 90 +/- 10), Follow up 2 ((Day 180+/-10)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Ravenell, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Pressure over 6 months (time frame: Initial Study Day 1, Follow up 1 (Day 90 +/- 10), Follow up 2 ((Day 180+/-10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.