Nashville - Hypertension Management Model

NCT04232124 | Completed Results DMC

• 1 other identifier: 191470
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Systolic and Diastolic Blood Pressure

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

  Baseline to 6 months

Study Arms (1)

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.

Behavioral: Hypertension Management Model

Interventions

Hypertension Management Model BEHAVIORAL

1. Blood Pressure readings by barbers 2. Clinical Pharmacist evaluation and counseling 3. Blood pressure measurement 4. Point of care basic metabolic panel measurement

Hypertension Management Model

Eligibility Criteria

• Age: 35 Years - 79 Years
• Gender Eligibility Details: Study population is black men.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of California, Los Angeles: collaborator
• Cedars-Sinai Medical Center: collaborator

Study Sites (2)

Vanderbilt University Medical Center

Nash, Tennessee, 37232, United States

Location

Masters Barbershop

Nashville, Tennessee, 37218, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: David G. Harrison
• Organization: Vanderbilt University Medical Center

david.g.harrison@vumc.org

6158753049

Study Officials

• David Harrison, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: February 15, 2020
• Primary Completion: July 15, 2021
• Study Completion: July 15, 2021
• Last Updated: January 22, 2024
• Results First Posted: January 22, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data is currently available. It will remain available until the study is closed.
• Access Criteria: IRB approval.

Locations

US (2)