Cut Your Pressure Too: The Los Angeles Barbershop Blood Pressure Study

NCT02321618 | Completed DMC

• 2 other identifiers: Pro000353475R01HL117983-02
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

African-American men suffer more than most other groups from hypertension (HTN) but often have less access and less contact with doctors. Previous work by the study's Principal Investigator in Dallas, Texas, and Altadena, California, showed that barbershops are an excellent place to identify black men with high blood pressure and to enlist the aid of their barbers as healthcare extenders. The purpose of this study in Metro Los Angeles (LA) is to compare two types of barber-based patient-centered blood pressure programs to see which type is more effective in improving the customers' high blood pressure. One type emphasizes blood pressure medication and the other type emphasizes lifestyle modification for high blood pressure.

Conditions

Hypertension

Keywords

Hypertension; High Blood Pressure; African American men; Black men; barbershop

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Secondary Blood Pressure Outcome - change in diastolic blood pressure

  6 months

• The percentage of participants achieving blood pressure goal

  6 months

• The change in number/type of drug classes prescribed

  6 months

• Adverse Drug Reactions

  6 months

• Self-Rated Health

  6 months

Other Outcomes (7)

• Extension Study Primary Blood Pressure Outcome - change in systolic blood pressure

  12 months

• Extension Study Secondary Blood Pressure Outcome - change in diastolic blood pressure

  12 months

• Extension Study Secondary Outcome - the percentage of participants achieving blood pressure goal

  12 months

Study Arms (2)

BP measurement & pharmacy

EXPERIMENTAL

BP measurements performed by barber, role model poster exposure in barbershop, and BP medication management visits with study pharmacist

Behavioral: BP measurement & pharmacy

BP educational materials

OTHER

Exposure to hypertension educational materials in barbershop

Behavioral: BP educational materials

Interventions

BP measurement & pharmacy BEHAVIORAL

Blood pressure monitoring by barber, blood pressure medication management by pharmacist, role model posters encouraging program participation

BP measurement & pharmacy

BP educational materials BEHAVIORAL

Exposure to hypertension educational materials

BP educational materials

Eligibility Criteria

• Age: 35 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 79 years of age
• Non-Hispanic Black men
• Long-term/frequent barbershop patronage (barbershop patrons having at least one haircut every 6 weeks in the same barbershop for the past 6 months).
• Systolic BP \>140 at 2 screenings on 2 separate days
• Complete set of Baseline Data

You may not qualify if:

• Women
• Children
• \<35 years of age
• Non-black
• Hispanic ethnicity
• New/infrequent patronage (\<8 haircuts at same barbershop in last 12 months)
• Systolic BP \<140 at either screening
• Currently receiving cancer chemotherapy
• On Dialysis
• Incomplete baseline data
• Serious Plan to Move in the next 1.5 years
• Plans to be out of the area for \> 1 month in the next 1.5 years

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• The California Endowment: collaborator
• University of California, Los Angeles: collaborator
• Lincy Foundation: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• Victor RG, Li N, Blyler CA, Mason OR, Chang LC, Moy NPB, Rashid MA, Weiss JP, Handler J, Brettler JW, Sagisi MB, Rader F, Elashoff RM. Nocturia as an Unrecognized Symptom of Uncontrolled Hypertension in Black Men Aged 35 to 49 Years. J Am Heart Assoc. 2019 Mar 5;8(5):e010794. doi: 10.1161/JAHA.118.010794.

  PMID: 30827133 DERIVED

• Victor RG, Blyler CA, Li N, Lynch K, Moy NB, Rashid M, Chang LC, Handler J, Brettler J, Rader F, Elashoff RM. Sustainability of Blood Pressure Reduction in Black Barbershops. Circulation. 2019 Jan 2;139(1):10-19. doi: 10.1161/CIRCULATIONAHA.118.038165.

  PMID: 30592662 DERIVED

• Victor RG, Lynch K, Li N, Blyler C, Muhammad E, Handler J, Brettler J, Rashid M, Hsu B, Foxx-Drew D, Moy N, Reid AE, Elashoff RM. A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops. N Engl J Med. 2018 Apr 5;378(14):1291-1301. doi: 10.1056/NEJMoa1717250. Epub 2018 Mar 12.

  PMID: 29527973 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Ronald G Victor, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIRECTOR, CEDARS-SINAI HYPERTENSION CENTER DIRECTOR OF CLINICAL RESEARCH & ASSOCIATE DIRECTOR, HEART INSTITUTE BURNS AND ALLEN CHAIR IN CARDIOLOGY RESEARCH

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: December 22, 2014
• Study Start: February 17, 2015
• Primary Completion: June 30, 2017
• Study Completion: January 9, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

US (1)