Clinical trial NCT02321618: Cut Your Pressure Too: The Los Angeles Barbershop Blood Pressure Study
Official title: Barber-Pharmacist Coordination to Improve Blood Pressure Management in Black Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
High Blood Pressure
African American men
Black men
barbershop
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
name: The California Endowment
name: University of California, Los Angeles
name: Lincy Foundation
First posted: 2014-12-22
Enrollment: 320
Sex: MALE
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Primary Blood Pressure Outcome - change in systolic blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: Secondary Blood Pressure Outcome - change in diastolic blood pressure
timeFrame: 6 months
measure: The percentage of participants achieving blood pressure goal
timeFrame: 6 months
measure: The change in number/type of drug classes prescribed
timeFrame: 6 months
measure: Adverse Drug Reactions
timeFrame: 6 months
measure: Self-Rated Health
timeFrame: 6 months
measure: Self-Rated Patient Engagement
timeFrame: 6 months
Other outcomes:
measure: Extension Study Primary Blood Pressure Outcome - change in systolic blood pressure
timeFrame: 12 months
measure: Extension Study Secondary Blood Pressure Outcome - change in diastolic blood pressure
timeFrame: 12 months
measure: Extension Study Secondary Outcome - the percentage of participants achieving blood pressure goal
timeFrame: 12 months
measure: Extension Study Secondary Outcome - the change in number/type of drug classes prescribed
timeFrame: 12 months
measure: Extension Study Secondary Outcome - adverse drug reactions
timeFrame: 12 months
measure: Extension Study Secondary Outcome - self-rated health
timeFrame: 12 months
measure: Extension Study Secondary Outcome - self-rated patient engagement
timeFrame: 12 months
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald G Victor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.