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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- Blood Pressure readings by barbers
- Clinical Pharmacist evaluation and counseling
- Blood pressure measurement
- Point of care basic metabolic panel measurement
| Study group | Role | What they receive |
|---|---|---|
| Hypertension Management Model | Experimental | Aim 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.
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.
- First posted18 Jan 2020
- Study start15 Feb 2020
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Harrison, Vanderbilt University Medical Center
- Investigators
- David Harrison, MD, Principal investigator, Vanderbilt University Medical Center
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the Los Angeles Barber - Pharmacist Model Hypertension Management in Nashville
- ClinicalTrials.gov ID
- NCT04232124
- Acronym / sponsor ID
- 191470
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Cedars-Sinai Medical Center
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 22 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hypertension Management Model | Experimental | Behavioral: Hypertension Management ModelAim 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. |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Severe cognitive impairment
- Non-fluent in English
- Women
- Age < 35 years or > 79 years
- Systolic BP < 140 mm Hg at either screening
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 |
|---|---|---|
| Hypertension Management Model1. Blood Pressure readings by barbers 2. Clinical Pharmacist evaluation and counseling 3. Blood pressure measurement 4. Point of care basic metabolic panel measurement | Behavioural | Hypertension Management Model |
Primary outcome
Change in Systolic and Diastolic Blood Pressure
Time frame: Baseline to 6 months
Blood pressure changes were quantified as the baseline minus the 6 month value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD will be shared with other researchers with IRB approvals and also approved data sharing agreements contracts.
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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.
David Harrison, MD principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
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.