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Nashville - Hypertension Management Model

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypertension Management Model
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

35 Years - 79 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Masters Barbershop
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypertension Management Model

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Systolic Blood Pressure
The study's primary clinical outcome is the change in systolic BP assessed 6 months after enrollment.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2020
Last Updated
November 7, 2021
Sponsor
Vanderbilt University Medical Center
Collaborators
University of California, Los Angeles, Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04232124
Brief Title
Nashville - Hypertension Management Model
Official Title
Implementing the Los Angeles Barber - Pharmacist Model Hypertension Management in Nashville
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
University of California, Los Angeles, Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertension Management Model
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hypertension Management Model
Intervention Description
Blood Pressure readings by barbers Clinical Pharmacist evaluation and counseling Blood pressure measurement Point of care basic metabolic panel measurement
Primary Outcome Measure Information:
Title
Change in Systolic Blood Pressure
Description
The study's primary clinical outcome is the change in systolic BP assessed 6 months after enrollment.
Time Frame
baseline and 6 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Study population is black men.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Harrison, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masters Barbershop
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37218
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nash
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared with other researchers with IRB approvals and also approved data sharing agreements contracts.
IPD Sharing Time Frame
Data is currently available. It will remain available until the study is closed.
IPD Sharing Access Criteria
IRB approval.

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Nashville - Hypertension Management Model

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