Cut Your Blood Pressure 3
Telemedicine and the Barbershop Model of Hypertension Care for Black Men
1 other identifier
interventional
10
1 country
1
Brief Summary
The recently published LA Barbershop in the New England Journal of Medicine (Victor et al. N Engl J Med 2018; 378: 1291-301) solid evidence of the efficacy of a pharmacist-led medication management intervention to reduce blood pressure in black men that patronize barbershops. One of the most significant logistical inefficiencies of the LA Barbershop Study was the amount of time the pharmacists spent driving for face-to-face visits with participants. On average, each round trip was 40 miles and pharmacists drove 2 hours per day. By using telemedicine, the study team can minimize the number of face-to-face in-person visits and increase pharmacist efficiency by 25%. the study team aim to increase the scalability of our novel, evidence-based barbershop model by addressing this inefficiency with the pilot study. In the LA Barbershop trial, each participant averaged 7 in-person visits in 6 months. the study team found that the initial in-person visits between the pharmacist, barber, and patron were essential for establishing trust as well as obtaining baseline electrolyte and serum creatinine levels (with our validated point-of-care device, iSTAT). However, once rapport has been established and blood pressure control achieved, the study team postulate that the effect can be maintained remotely with telemedicine. Our data indicate that most patients' can achieve their blood pressure goal in 3 months or less. the study team propose replacing additional in-person visits with telemonitoring (via Skype or FaceTime) at this juncture, provided blood chemistries are stable. the study team plan to pilot this in 20 patients from 2 to 3 barbershops for 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
October 31, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedFebruary 4, 2021
February 1, 2021
1.4 years
October 30, 2018
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Primary Blood Pressure Outcome - Change in Systolic Blood Pressure
The Pre-Specified primary outcome was the change in systolic blood pressure from baseline to 6 months follow-up.
6 months
Primary Blood Pressure Outcome - Change in Systolic Blood Pressure
The Pre-Specified primary outcome was the change in systolic blood pressure from baseline to 12 months follow-up.
12 months
Study Arms (1)
Blood Pressure measurement and pharmacy
EXPERIMENTALBlood Pressure measurement performed by barber and Blood pressure measurement and management visits with study pharmacist in person and through Telemedicine.
Interventions
Blood Pressure monitoring by barber, Blood pressure measurement and management by pharmacist in person and through telemedicine
Eligibility Criteria
You may qualify if:
- Non-Hispanic Black Men
- Age 35 to 79 years-old
- Able to give informed consent
- Long-term/frequent barbershop patronage (\>8 haircuts at the same barbershop in the last 12 months)
- systolic BP ≥140 on 2 different screening days, and complete set of baseline data
- Each participant should have their own personal smart cell phone with video chat capability (needed for telemedicine)
You may not qualify if:
- Women
- Men \< 35 years old or Men \>79 years old
- Non-black
- Hispanic Ethnicity
- New/infrequent patronage (\<8 haircuts at same barbershop in last 12 months);
- Kidney dialysis.
- Receiving chemotherapy for cancer. Systolic BP \<140 at either screening and incomplete baseline data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cedars-Sinai Medical Centerlead
- Medtronic Foundationcollaborator
- University of California, Los Angelescollaborator
Study Sites (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Related Publications (1)
Blyler CA, Ebinger J, Rashid M, Moy NP, Cheng S, Albert CM, Rader F. Improving Efficiency of the Barbershop Model of Hypertension Care for Black Men With Virtual Visits. J Am Heart Assoc. 2021 Jul 6;10(13):e020796. doi: 10.1161/JAHA.120.020796. Epub 2021 Jun 22.
PMID: 34155907DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- Co-Director, Clinic for Hypertrophic Cardiomyopathy and Aortopathies ; Assistant Director, Non-invasive Laboratory; Hypertension Center of Excellence
Study Record Dates
First Submitted
October 30, 2018
First Posted
October 31, 2018
Study Start
November 1, 2018
Primary Completion
April 1, 2020
Study Completion
October 15, 2020
Last Updated
February 4, 2021
Record last verified: 2021-02