About this trial
The original, "Cut Your Pressure Too: The LA Barbershop Blood Pressure Study (LABBPS)" (NCT02321618) was a highly successful cluster-randomized trial of a community centered blood pressure (BP) reduction program focused on Non-Hispanic (NH) black men who experience the highest rates of hypertension (HTN) and its complications. Patrons of 52 barbershops in Los Angeles County were randomly assigned to either an intervention arm in which barbers encouraged meetings with trained clinical pharmacists who provided HTN treatment in the barbershops or a control arm in which barbers provided educational pamphlets on HTN and encouraged physician appointments. After 6 months, the intervention group had a statistically significant reduction in systolic BP (SBP) of 21.6 mmHg compared to the control group. Results were durable at 1 year. Thereafter, a pilot study (NCT03726710) aimed at improving the efficiency of the barbershop model of HTN care by substituting in-person visits with video visits once BP was at goal was undertaken in 10 hypertensive barbershop patrons. The intervention effect was unchanged. The current study represents Aim 3 of an NIH funded renewal application entitled, "Barber and Pharmacist Coordination to Improve Blood Pressure Management in Black Men." It will build upon the foundational work of the original study and telemedicine pilot by evaluating the efficacy of a fully remote hypertension management program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 35-79
Self-identify as NH Black male
Documented systolic BP ≥ 140 mmHg on 2 or more separate screening days. The second BP assessment must be completed within a 4-week period
Regularly attend the same barbershop (barbershop patrons having at least one haircut every 6 weeks in the same barbershop for the past 6 months)
Disqualifiers
Ages <35 or >79 years
Arm circumference incompatible with the BP device
Severe cognitive impairment
Non-fluent in English
Trial design
Single group
Treatments tested in this trial
Telemedicine Barbershop BP Reduction
Other interventionTest feasibility, acceptability, and effectiveness of an adapted blood pressure reduction intervention that moves the LABBPS in-person clinical pharmacist to a telemedicine platform inside of the barbershop.
Treatment groups
Trial outcomes
Primary outcomes
Change in Systolic Blood Pressure (SBP)
The primary outcome will be the difference in SBP measured at 6 months compared to enrollment.
Secondary outcomes
Change in Diastolic Blood Pressure (DBP)
1. Difference in DBP measured at 6 months compared to enrollment 2. Achievement of goal BP, 6 months, Proportion of participants achieving SBP \<130 mm Hg AND DBP \<80 mm Hg 3. Medication Intensification, 6 months, Difference in the number of BP drugs of different classes at 6 months compared to enrollment 4. First-line medication use, 6 months, Difference in percentage of participants receiving first-line BP drug classes at 6 months compared to enrollment 5. Recruitment and retention rates will be quantified to assess feasibility 6. Acceptability to barbers and participants
Sponsors and contacts
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Cedars-Sinai Medical Center
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
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