Cut Your Pressure Too: The Altadena Barbershop Blood Pressure Study, Phase 2 (Intervention Pilot Study)
NCT ID: NCT02198144
Last Updated: 2014-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
14 participants
INTERVENTIONAL
2009-08-31
2013-07-31
Brief Summary
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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.
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Detailed Description
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ROLE MODEL STORIES (DEVELOPMENT OF HEALTH MESSAGING TOOLS) 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 they 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. The Cedars-Sinai research team will interview selected participants who are already adopters of our new program, to serve as models for their peers and write the model stories that will be displayed in the barbershop. Each story will model one specific behavior, one influencing factor, and one positive outcome. 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. A signed memo of agreement will be obtained from each model to record and display their story and anyone who is pictured in the story will also sign a memo of agreement to participate. The model will approve the final draft of the poster before being displayed in the barbershop, and control of high blood pressure. The Cedars-Sinai research team will interview selected participants who are already adopters of our new program, to serve as models for their peers and write the model stories that will be displayed in the barbershop. Each story will model one specific behavior, one influencing factor, and one positive outcome. Each role model story will encourage one of two desired health behaviors of potential subjects with elevated BP: 1) ask the barber to check patient's 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. A signed memo of agreement will be obtained from each model to record and display their story and anyone who is pictured in the story will also sign a memo of agreement to participate. The model will approve the final draft of the poster before being displayed in the barbershop.
AME11226: The investigators are requesting an amendment to our original protocol in order to pilot test a six-month Minimal Maintenance Phase that will follow the six-month Intervention Phase. The barber will continue to monitor participants' blood pressure but the study pharmacists will limit their interaction to phone calls (vs. face-to-face visits as in the Intervention Phase). In addition, all study compensation for participants will be discontinued. The goal of discontinuing such compensation is to demonstrate that participants will continue to be proactive about controlling their blood pressure as a result of intrinsic motivation with continued social support from the barber and minimal phone follow-up with the pharmacist.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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barbershop-based BP measurement
BP monitoring by barbershop based Barbers and BP lowering medication(s)
barbershop-based BP measurement
BP Measurements and blood pressure reducing medication
Interventions
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barbershop-based BP measurement
BP Measurements and blood pressure reducing medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular (unsolicited) customer of this barbershop.
* There is no upper age limit
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Cedars-Sinai Medical Center
OTHER
Responsible Party
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Ron Victor
Director, Hypertension Center of Excellence
Principal Investigators
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Ronald Victor, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Jeffery Wilkins, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinail Medical Center
Los Angeles, California, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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BARBER-1
Identifier Type: -
Identifier Source: org_study_id
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