Hypertension Clinical Trial
Official title:
Telemedicine and the Barbershop Model of Hypertension Care for Black Men
NCT number | NCT03726710 |
Other study ID # | 54480 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2018 |
Est. completion date | October 15, 2020 |
Verified date | February 2021 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | October 15, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 35 Years to 79 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center | Medtronic Foundation, University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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