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HypertensionNCT04232124

Nashville - Hypertension Management Model

A study testing Hypertension Management Model in people with Hypertension, run by Vanderbilt University Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Black men face a shorter life expectancy than white men due to poorer health outcomes associated with many chronic diseases, most notably hypertension and its cardiovascular complications. A lack of access to healthcare resources and poor engagement with healthcare providers drive these inequities. Read more about this study

Who is it for?
Ages 35 to 79 years, men only
Conditions the study is for
Hypertension
What is being tested?
Hypertension Management Model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesUnited States
Study dates
15 Feb 2020to 15 Jul 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 35 to 79 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults 35-79 years old
  • Self - identify as Non-Hispanic black male
  • Patron of one of the participating barbershops (4 haircuts in the last 6 months)
  • Systolic BP> 140mm Hg on two screening days at least one day apart

Who cannot join

  • Severe cognitive impairment
  • Non-fluent in English
  • Women
  • Age < 35 years or > 79 years
  • Systolic BP < 140 mm Hg at either screening
  • Currently receiving chemotherapy for cancer
Show all 10Show fewer
  • Organ transplant patient
  • Currently receiving dialysis
  • Other conditions the physician investigator deem unsafe to participate
  • Plans to move/relocate in next 12 months and/or travel out of area for > 1 month

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Vanderbilt University Medical Center

    Nash, Tennessee, 37232

  • Masters Barbershop

    Nashville, Tennessee, 37218

Other trials in United States

About this study

Official title: Implementing the Los Angeles Barber - Pharmacist Model Hypertension Management in Nashville

Black men face a shorter life expectancy than white men due to poorer health outcomes associated with many chronic diseases, most notably hypertension and its cardiovascular complications. A lack of access to healthcare resources and poor engagement with healthcare providers drive these inequities. A seminal trial conducted in the Metro Los Angeles area demonstrated the effectiveness of using collaborative care partnerships between black-owned barbershops and pharmacists to reduce blood pressure in black men.

The purpose of this study is to test the feasibility and success of implementing a single-arm, smaller-scale version of the Los Angeles study in the Nashville area to provide additional empiric support for collaborative care partnerships to treat hypertension in other geographic locations.

Read the detailed description

Uncontrolled hypertension (HTN) is a significant risk factor for mortality among non-Hispanic black men, and black men have the highest incidence of death from HTN of any race, ethnic, or gender group in the United States. Sustained, trusting interactions with healthcare professionals and a lack of access to healthcare resources are both significant drivers of these disparities. A cluster, randomized controlled trial in the Metro Los Angeles area demonstrated that health promotion by black barbers resulted in greater reductions in blood pressure (BP) when combined with medication management by specialty-trained pharmacists, as compared to health promotion by barbers alone.

The purposes of this single arm, pre-test/post-test study are to a) establish an effective network of barbershop research hubs in Nashville, b) test the feasibility of engaging with a specialty-trained pharmacist in collaboration with a barbershop to treat blood pressure in black men, and c) create a local registry of potential subjects as a platform for enrolling black men in future studies. There is no central hypothesis in this pilot implementation study, but the study will evaluate the ability of the barbershop-based research methodology to recruit and retain black men in a study; the fidelity to the intervention by barbers, the pharmacist, and the hypertensive male participants; and the effectiveness of the intervention on systolic blood pressure reduction and patient satisfaction. All participants will also be offered the opportunity to participate in a separate research registry for recruitment into future studies.

Research staff will offer free BP screening to all adult black men entering each shop for approximately 4 weeks, or until recruitment targets have been met. Patrons with a systolic BP > 140 mm Hg on two separate occasions will be eligible to participate. The patrons' existing physician or the lead physician or a study physician will sign a collaborative practice agreement for a specialty-trained pharmacist to provide care and prescribe BP medications within the study protocol. All participants in this study will execute a visit with the study physician for an evaluation to establish care, supported by the funding for this proposal.

Barbers will participate in training related to skills on BP measurement and counseling performed by either collaborating researchers from the University of California, Los Angeles-Cedars Sinai or from local study personnel. Barbers will frequently check and transmit the BP readings of their enrolled patrons and motivate them to work with the clinical pharmacist, who will meet them in their barbershops to optimize BP medication. The pharmacist will promote patient activation, intensify drug therapy under a collaborative practice agreement as permitted by Tennessee state law, send progress notes to the participant's physicians, and ensure appropriate safety monitoring after each medication change.

Conditions
Hypertension
Being tested
Hypertension Management Model
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypertension Management ModelBehavioural

    1. Blood Pressure readings by barbers
    2. Clinical Pharmacist evaluation and counseling
    3. Blood pressure measurement
    4. Point of care basic metabolic panel measurement
Study groups in NCT04232124
Study groupRoleWhat they receive
Hypertension Management ModelExperimentalAim 1. Execute a smaller version of the LA Barbershop BP Study through the new Nashville network as the test case for: A) recruiting regular patrons with uncontrolled HTN, B) conducting a research protocol and evaluating a HTN intervention; and C) creating a local registry of potential subjects as platform for enrolling black men in future research studies.
Receives: Behavioral: Hypertension Management Model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Systolic and Diastolic Blood Pressure

    Blood pressure changes were quantified as the baseline minus the 6 month value.

    Measured: Baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2020
  2. Study start15 Feb 2020
  3. Primary completion15 Jul 2021
  4. Study completion15 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Execute a smaller version of the LA Barbershop BP Study through the new Nashville network as the test case for: A) recruiting regular patrons with uncontrolled HTN, B) conducting a research protocol and evaluating a HTN intervention; and C) creating a local registry of potential subjects as platform for enrolling black men in future research studies.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04232124
Sponsor's protocol ID
191470
Status last verified
Apr 2023
First submitted
14 Jan 2020
Last updated
22 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be shared with other researchers with IRB approvals and also approved data sharing agreements contracts.

Questions about this trial

What is this clinical trial studying?

A study testing Hypertension Management Model in people with Hypertension, run by Vanderbilt University Medical Center at 2 sites 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 4 inclusion and 10 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 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 22 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Systolic and Diastolic Blood Pressure (time frame: Baseline to 6 months). 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 22 Jan 2024.

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