NCT00325533

Brief Summary

Black men in the United States have a greater risk of developing high blood pressure than men of any other ethnic or racial group. The purpose of this study is to evaluate the effectiveness of a high blood pressure detection and medical referral program conducted by barbers in predominantly Black barbershops at increasing awareness and lowering blood pressure levels among their Black male customers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,319

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started May 2006

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 12, 2014

Status Verified

July 1, 2009

Enrollment Period

2.6 years

First QC Date

May 12, 2006

Last Update Submit

June 11, 2014

Conditions

Hypertension

Keywords

Blood Pressure, HighBlacksAfrican Americans

Outcome Measures

Primary Outcomes (1)

  • Percentage of customers with high blood pressure who achieve recommended systolic and diastolic blood pressure values

    Measured at 12 months

Secondary Outcomes (2)

  • Customer recognition of elevated blood pressure levels

    Measured at 12 months

  • Number of customers with high blood pressure with a regular medical provider

    Measured at 12 months

Study Arms (2)

Screening & Enhanced Intervention

EXPERIMENTAL

After an intensive 10-week baselne screening, the enhanced intervention group barbers will be trained to measure blood pressure and deliver health messages related to blood pressure control during each customer's visit.

Behavioral: Baseline BP ScreeningOther: Intensive 10-week Blood Pressure Screening

Screening

ACTIVE COMPARATOR

After the intensive 10-week baseline BP screening (an intervention in itself), the barbershops in the comparison arm received a continual supply of American Heart Association pamphlets on Hypertension in African Americans.

Other: Intensive 10-week Blood Pressure Screening

Interventions

Baseline BP ScreeningBEHAVIORAL

Barbers in the barbershops in the experimental arm will be trained to accurately measure and interpret blood pressure (BP). Each barber will offer a BP check to customers with each haircut, complete an encounter form after each haircut, discuss the BP reading with the customer, identify customers with elevated BP, and refer customers with elevated BP to a regular physician or other primary provider for long-term BP management. Each time a customer with elevated BP goes to a regular medical provider, he receives a free haircut, and the referring barber receives a monetary bonus.

Screening & Enhanced Intervention
Intensive 10-week Blood Pressure ScreeningOTHER

Intensive 10-week Blood Pressure Screening

ScreeningScreening & Enhanced Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • African American
  • Regular customer at one of the participating barbershops

You may not qualify if:

  • Does not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8586, United States

Location

Related Publications (3)

  • Rader F, Elashoff RM, Niknezhad S, Victor RG. Differential treatment of hypertension by primary care providers and hypertension specialists in a barber-based intervention trial to control hypertension in Black men. Am J Cardiol. 2013 Nov 1;112(9):1421-6. doi: 10.1016/j.amjcard.2013.07.004. Epub 2013 Aug 23.

    PMID: 23978276DERIVED

  • Victor RG, Ravenell JE, Freeman A, Leonard D, Bhat DG, Shafiq M, Knowles P, Storm JS, Adhikari E, Bibbins-Domingo K, Coxson PG, Pletcher MJ, Hannan P, Haley RW. Effectiveness of a barber-based intervention for improving hypertension control in black men: the BARBER-1 study: a cluster randomized trial. Arch Intern Med. 2011 Feb 28;171(4):342-50. doi: 10.1001/archinternmed.2010.390. Epub 2010 Oct 25.

    PMID: 20975012DERIVED

  • Victor RG, Ravenell JE, Freeman A, Bhat DG, Storm JS, Shafiq M, Knowles P, Hannan PJ, Haley R, Leonard D. A barber-based intervention for hypertension in African American men: design of a group randomized trial. Am Heart J. 2009 Jan;157(1):30-6. doi: 10.1016/j.ahj.2008.08.018.

    PMID: 19081393DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Ronald G. Victor, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

June 12, 2014

Record last verified: 2009-07

Locations

US(1)