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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02321618
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : July 10, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
The California Endowment
University of California, Los Angeles
Lincy Foundation
Information provided by (Responsible Party):
Ron Victor, Cedars-Sinai Medical Center

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.


Condition or disease Intervention/treatment Phase
Hypertension Behavioral: BP measurement & pharmacy Behavioral: BP educational materials Not Applicable

Detailed Description:

Uncontrolled hypertension (HTN) is one of the most important causes of premature disability and death among non-Hispanic black men. Indeed, black men have the highest HTN death rate of any U.S. race, ethnic, or gender group, contributing to a lower life expectancy. The age-adjusted HTN-related death rate is 3.3-times higher among black men than white men. To address this major health disparity, the investigators designed a novel community-partnered team approach to improve HTN management among black men and prevent needless strokes, heart attacks, kidney failure, and heart failure.

HTN requires physician (or middle-level provider) interaction to optimize blood pressure (BP) medication; black men have less interaction than black women; and thus far lower rates of HTN treatment (73% vs. 86%) and control (36% vs. 50%). Black-owned barbershops are a uniquely personal setting to discuss health with influential male peers. Barbershop health outreach is well-established, but untested as a vehicle for improving HTN control. Scientific evaluation is crucial to best allocate finite healthcare dollars and avoid promoting a "community health industry" that benefits only the promoters.

Under-treatment of HTN is common in primary care due to competing demands on physicians' time. The best way to improve HTN control is with team-based approaches enlisting pharmacists. They are more accessible than physicians, more knowledgeable about medication, and receive training on patient education. The investigators' new conceptual model links the barber-based intervention to team-based care delivery.

The purpose of this research study is to compare this new conceptual model to another barber-based patient-centered blood pressure program to see which is more effective in improving high blood pressure among Black patrons of African American owned barbershops in LA. Patrons randomized to Group 1 (the new conceptual model) will provide blood pressure readings for patrons aged 35 to 79 years of age and refer those with HTN to a Clinical Pharmacist to work with their doctors in optimizing blood pressure medication.

Patrons of Group 1 shops will also be exposed to role model posters are not intended as recruitment materials, but rather are educational tools that intend to highlight positive experiences of participation. The text of the role model stories will in no way provide statements of the effectiveness of the intervention being evaluated by the present research study. Rather, they are the main health messaging tools needed to promote completion of the program in order to achieve the experiences described. Essentially the document will be used as an intervention tool for peer-based health messaging - stories from real customers in the barbershop modeling target behaviors leading that promote continued participation in the protocol by peers with the hopes of achieving to the detection, treatment, and control of high blood pressure. Each role model story will encourage one of two desired health behaviors of potential subjects with elevated BP: 1) ask the barber to check patients' BP with each haircut, 2) schedule a follow-up visit with the study pharmacist to get patient's blood pressure under control. Large posters in the barbershop will show the model customer, his barber, and the study pharmacist who facilitated the desired behavior change. The model's (participants) own words will be used on the poster.

Group 2 barbershop patrons will be exposed to up-to-date information on high blood pressure and on lifestyle topics for blood pressure and heart health including weight management, healthy cooking, cholesterol lowering, and exercise.

A pre-specified cross-sectional sub study utilized the trial's initial screening population to test for an association between self-reported nocturia (>2 nightly/voids) and elevated daytime (in-barbershop) blood pressure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Barber-Pharmacist Coordination to Improve Blood Pressure Management in Black Men
Actual Study Start Date : February 17, 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : January 9, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BP measurement & pharmacy
BP measurements performed by barber, role model poster exposure in barbershop, and BP medication management visits with study pharmacist
Behavioral: BP measurement & pharmacy
Blood pressure monitoring by barber, blood pressure medication management by pharmacist, role model posters encouraging program participation

BP educational materials
Exposure to hypertension educational materials in barbershop
Behavioral: BP educational materials
Exposure to hypertension educational materials




Primary Outcome Measures :
  1. Primary Blood Pressure Outcome - change in systolic blood pressure [ Time Frame: 6 months ]
    The pre-specified primary outcome was the change in systolic blood pressure from baseline to 6 months follow-up.


Secondary Outcome Measures :
  1. Secondary Blood Pressure Outcome - change in diastolic blood pressure [ Time Frame: 6 months ]
    The change in diastolic blood pressure from baseline to 6 month follow-up

  2. The percentage of participants achieving blood pressure goal [ Time Frame: 6 months ]
    The percentage of participants who achieved blood pressure goal after 6 months follow-up (140/90,135/85, 130/80)

  3. The change in number/type of drug classes prescribed [ Time Frame: 6 months ]
    The change in number/class of prescription drugs prescribed from baseline to 6 month follow-up

  4. Adverse Drug Reactions [ Time Frame: 6 months ]
    The number and type of adverse drug reactions reported from baseline to 6 month follow-up

  5. Self-Rated Health [ Time Frame: 6 months ]
    The change in self-rated health score from baseline to 6 month follow-up

  6. Self-Rated Patient Engagement [ Time Frame: 6 months ]
    The change in PACIC patient engagement score from baseline to 6 month follow-up


Other Outcome Measures:
  1. Extension Study Primary Blood Pressure Outcome - change in systolic blood pressure [ Time Frame: 12 months ]
    The primary outcome of the extension study is the change in systolic blood pressure from baseline to 12 months follow-up.

  2. Extension Study Secondary Blood Pressure Outcome - change in diastolic blood pressure [ Time Frame: 12 months ]
    The change in diastolic blood pressure from baseline to 12 month follow-up

  3. Extension Study Secondary Outcome - the percentage of participants achieving blood pressure goal [ Time Frame: 12 months ]
    The percentage of participants who achieved blood pressure goal after 12 months follow-up (140/90,135/85, 130/80)

  4. Extension Study Secondary Outcome - the change in number/type of drug classes prescribed [ Time Frame: 12 months ]
    The change in number/class of prescription drugs prescribed from baseline to 12 month follow-up

  5. Extension Study Secondary Outcome - adverse drug reactions [ Time Frame: 12 months ]
    The number and type of adverse drug reactions reported from baseline to 12 month follow-up

  6. Extension Study Secondary Outcome - self-rated health [ Time Frame: 12 months ]
    The change in self-rated health from baseline to 12 month follow-up

  7. Extension Study Secondary Outcome - self-rated patient engagement [ Time Frame: 12 months ]
    The change in PACIC patient engagement score from baseline to 12 month follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 35 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321618


Locations
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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
The California Endowment
University of California, Los Angeles
Lincy Foundation
Investigators
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Principal Investigator: Ronald G Victor, MD Cedars-Sinai Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ron Victor, DIRECTOR, CEDARS-SINAI HYPERTENSION CENTER DIRECTOR OF CLINICAL RESEARCH & ASSOCIATE DIRECTOR, HEART INSTITUTE BURNS AND ALLEN CHAIR IN CARDIOLOGY RESEARCH, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02321618    
Other Study ID Numbers: Pro00035347
5R01HL117983-02 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Ron Victor, Cedars-Sinai Medical Center:
Hypertension
High Blood Pressure
African American men
Black men
barbershop
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases