HypertensionNCT00325533
Effectiveness of a Barbershop-Based Program to Improve High Blood Pressure Control and Awareness in Black Men
A study testing Baseline BP Screening and Intensive 10-week Blood Pressure Screening in people with Hypertension, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Baseline BP Screening and Intensive 10-week Blood Pressure Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,319 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- African American
- Regular customer at one of the participating barbershops
Who cannot join
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8586
About this study
Official title: Group Randomized Trial of a Barber-Based Intervention to Improve Hypertension Control in Black Men
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.
Read the detailed description
High blood pressure affects approximately 35% of Black men in the United States. This may be due to the fact that Black men frequently have an unusually high number of risk factors for high blood pressure, including diabetes, high stress levels, and increased salt intake and sensitivity. While high blood pressure can often be controlled through diet, lifestyle changes, or medication, it is a chronic asymptomatic medical condition for which individuals should remain under the care of a regular medical provider. A predominantly Black barbershop may be an optimum and receptive setting for an intervention that focuses on improving the detection and treatment of high blood pressure among Black men. In this study, barbers, deemed as influential peers, will be trained to continually monitor their customers' blood pressure, deliver health messages designed to change risk perception and ideas about healthcare utilization, and provide social support for changes in healthcare-seeking behavior and blood pressure levels. The purpose of this study is to evaluate the effectiveness of a barbershop-based intervention at increasing blood pressure awareness and lowering blood pressure levels among Black male customers. With over 18,000 Black barbershops in the United States, the results from this study may be extremely influential in improving the diagnosis and treatment of high blood pressure in Black men.
This study will enroll Black men who are regular customers at a participating barbershop. Each barbershop will be randomly assigned to either a 10-month intervention group or a control group. Nurses will train the intervention group barbers to measure blood pressure and deliver health messages related to blood pressure control during each customer's visit. Before and after the intervention, study researchers will interview barbers and customers over an 8-week period to collect information on blood pressure control. A 12-month follow-up visit will include assessments of blood pressure levels, customer recognition of elevated blood pressure levels, and the number of customers receiving regular medical care.
- Conditions
- Hypertension
- Being tested
- Baseline BP Screening, Intensive 10-week Blood Pressure Screening
- Keywords
- Blood Pressure, High, Blacks, African Americans
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline BP ScreeningBehavioural
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.
Intensive 10-week Blood Pressure ScreeningOther
Intensive 10-week Blood Pressure Screening
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Baseline BP Screening; Other: 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. Receives: Other: Intensive 10-week Blood Pressure Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of customers with high blood pressure who achieve recommended systolic and diastolic blood pressure values
Measured: Measured at 12 months
Secondary outcomes (2)
Customer recognition of elevated blood pressure levels
Measured: Measured at 12 months
Number of customers with high blood pressure with a regular medical provider
Measured: Measured at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Texas Southwestern Medical Center, Donald W. Reynolds Foundation
- Investigators
- Ronald G. Victor, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00325533
- Sponsor's protocol ID
- 470
- Other IDs
- R01HL080582, 55341, R01HL080582-01A2
- Status last verified
- Jul 2009
- First submitted
- 12 May 2006
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23978276Victor 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.
PubMed 20975012Victor 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.
PubMed 19081393
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Randomized Trial of a Barber-Based Intervention to Improve Hypertension Control in Black Men
- ClinicalTrials.gov ID
- NCT00325533
- Acronym / sponsor ID
- 470
- Conditions
- Hypertension
- Keywords
- Blood Pressure, High, Blacks, African Americans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,319 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Texas Southwestern Medical Center, Donald W. Reynolds Foundation
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 15 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
High blood pressure affects approximately 35% of Black men in the United States. This may be due to the fact that Black men frequently have an unusually high number of risk factors for high blood pressure, including diabetes, high stress levels, and increased salt intake and sensitivity. While high blood pressure can often be controlled through diet, lifestyle changes, or medication, it is a chronic asymptomatic medical condition for which individuals should remain under the care of a regular medical provider. A predominantly Black barbershop may be an optimum and receptive setting for an intervention that focuses on improving the detection and treatment of high blood pressure among Black men. In this study, barbers, deemed as influential peers, will be trained to continually monitor their customers' blood pressure, deliver health messages designed to change risk perception and ideas about healthcare utilization, and provide social support for changes in healthcare-seeking behavior and blood pressure levels. The purpose of this study is to evaluate the effectiveness of a barbershop-based intervention at increasing blood pressure awareness and lowering blood pressure levels among Black male customers. With over 18,000 Black barbershops in the United States, the results from this study may be extremely influential in improving the diagnosis and treatment of high blood pressure in Black men.
This study will enroll Black men who are regular customers at a participating barbershop. Each barbershop will be randomly assigned to either a 10-month intervention group or a control group. Nurses will train the intervention group barbers to measure blood pressure and deliver health messages related to blood pressure control during each customer's visit. Before and after the intervention, study researchers will interview barbers and customers over an 8-week period to collect information on blood pressure control. A 12-month follow-up visit will include assessments of blood pressure levels, customer recognition of elevated blood pressure levels, and the number of customers receiving regular medical care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening & Enhanced Intervention | Experimental | Behavioral: Baseline BP Screening, Other: Intensive 10-week Blood Pressure ScreeningAfter 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. |
| Screening | Active comparator | Other: Intensive 10-week Blood Pressure ScreeningAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- African American
- Regular customer at one of the participating barbershops
Key exclusion criteria (1 listed)
- Does not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline BP ScreeningBarbers 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. | Behavioural | Screening & Enhanced Intervention |
| Intensive 10-week Blood Pressure ScreeningIntensive 10-week Blood Pressure Screening | Other | Screening, Screening & Enhanced Intervention |
Primary outcome
Percentage of customers with high blood pressure who achieve recommended systolic and diastolic blood pressure values
Time frame: Measured at 12 months
2 secondary outcomes
Customer recognition of elevated blood pressure levels
Time frame: Measured at 12 months
Number of customers with high blood pressure with a regular medical provider
Time frame: Measured at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2014.
- Derived from this study: PubMed 23978276Rader 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.
- Derived from this study: PubMed 20975012Victor 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.
- Derived from this study: PubMed 19081393Victor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald G. Victor, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline BP Screening and Intensive 10-week Blood Pressure Screening in people with Hypertension, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of customers with high blood pressure who achieve recommended systolic and diastolic blood pressure values (time frame: Measured at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00325533, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2014.