Barber and Pharmacist Coordination to Improve Blood Pressure Management

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age35-79
SponsorCedars-Sinai Medical Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Telemedicine Barbershop BP Reduction

    Other intervention

    Test 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change in Systolic Blood Pressure (SBP)

The primary outcome will be the difference in SBP measured at 6 months compared to enrollment.

Time frame
6 months

Secondary outcomes

1

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

Time frame
6 months

Other outcomes

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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