Cut Your Pressure Too: The Altadena Barbershop Blood Pressure Study, Phase 2 (Intervention Pilot Study)

NCT02198144 | Completed

• 2 other identifiers: BARBER-1R01HL080582
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

African American men have the highest risk of any group for early death \& disability from high blood pressure (BP). Clinical investigations in Dallas, TX demonstrated that African American men with high BP are able to improve their BPs when participants agree to have their BP measured at their barbershop by their barber \& also take BP reducing medication as instructed by a healthcare team that includes their doctor. The goal of this study is to bring a barbershop-based model of BP measurement, treatment \& follow-up from Dallas, TX to the Southern California area. This study is the 2nd of two "Barbershop" studies at Cedars-Sinai Medical Center. The 1st study was called the "Barber-Based Intervention for Hypertension in Black Men: Baseline Data Collection." In this 2nd study at Wally's barbershop, the Investigators will enlist pharmacists to integrate the community health promotion program in barbershops into the healthcare system. Barbers are uniquely positioned to facilitate hypertension case detection \& referral, pharmacists are uniquely positioned to facilitate case management. Pharmacists have extensive knowledge of BP medication \& they have earned the respect of patients and physicians alike. In this intervention study, barbers will be trained to measure the BP \& refer those who have already been identified as having high BP to a community pharmacist for confirmation of uncontrolled high BP \& development of a BP management plan. The pharmacist will work with the customers' physicians to optimize the BP medication prescribed \& with individual customers to provide a user-friendly "medical home." Pharmacists will improve the customer's access to state-of-the-art medical care, The data from this study will be used to apply for a new NIH Grant. In addition, the summarized data will be shared with key stakeholders in the local community (including barbers, patrons, local healthcare providers, local pharmacists \& other community leaders) to design a larger community-partnered intervention. Specific Aims: Aim 1. To evaluate the impact of the new intervention model on HTN control in African American males. Aim 2. To evaluate the cost-effectiveness of the new intervention. The investigators hypothesize that the projected cost-savings to the healthcare system in reduced heart attack \& stroke care will outweigh intervention \& medication costs.

Conditions

Hypertension

Keywords

Hypertension; High Blood Pressure; African American Men; Black Men

Outcome Measures

Primary Outcomes (1)

• out-of-office blood pressure

  The six-month Intervention Phase is a final blood pressure reading by research staff in the barbershop, with a goal of \< 135/85 mmHg (the recommended goal for out-of-office blood pressure).

  Six-months

Secondary Outcomes (1)

• Health Questionnaire

  Six Months

Study Arms (1)

barbershop-based BP measurement

OTHER

BP monitoring by barbershop based Barbers and BP lowering medication(s)

Other: barbershop-based BP measurement

Interventions

barbershop-based BP measurement OTHER

BP Measurements and blood pressure reducing medication

Also known as: BP measurenents at their barbershop & BP reducing medication

barbershop-based BP measurement

Eligibility Criteria

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

You may qualify if:

• Adult (18 years of age or older) African-American male
• Regular (unsolicited) customer of this barbershop.
• There is no upper age limit

You may not qualify if:

• Self-assigned race/ethnicity other than African-American/ non-Hispanic black
• Female gender
• In barbershops that cater to African-American men, approximately 2% of the clientele are women. The female customers will not be surveyed but may be offered a free blood pressure screening.
• Age \< 18
• Children will not be surveyed because the prevalence of the condition being studied (hypertension) is low and does not justify the added logistical difficulties in obtaining informed consent. Although the population surveyed will be restricted to adult black men, the barbershop provides an excellent setting to foster blood pressure screening in children and adolescents who comprise 15-20% of the barbershop clientele. During the study period, staff may offer blood pressure screening to all children accompanied by a parent and to all adolescents.
• Language other than English

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cedars-Sinail Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (3)

• 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: 20975012 RESULT

• 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: 23978276 RESULT

• 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: 19081393 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ronald Victor, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Jeffery Wilkins, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hypertension Center of Excellence

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: July 23, 2014
• Study Start: August 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 23, 2014

Record last verified: 2014-07

Locations

US (1)