HypertensionNCT02198144
Cut Your Pressure Too: The Altadena Barbershop Blood Pressure Study, Phase 2 (Intervention Pilot Study)
A study testing barbershop-based BP measurement in people with Hypertension, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- barbershop-based BP measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 years of age or older) African-American male
- Regular (unsolicited) customer of this barbershop.
- There is no upper age limit
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinail Medical Center
Los Angeles, California, 90048
About this study
Official title: Barber-Based Intervention for Hypertension in Black Men: Follow-Up Evaluation
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:
Read more
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.
Read the detailed description
This study is the second of two "Barbershop" studies at Cedars-Sinai Medical Center. The first study at Wally's Barbershop in Altadena, CA was called the "Barber-Based Intervention for Hypertension in Black Men: Baseline Data Collection." Men at Wally's barbershop who were found to have high blood pressure as a participant in the first study are now being asked to participate in the second Cedars-Sinai study. During this second study the men will be asked to (1) return to Wally's barbershop to have their blood pressure measured to see how they are doing now, (2) review any medicines participants are taking, and (3) work with a health care team that includes their doctor, personal barber, and a pharmacist, to help them improve their blood pressure management. This second study is a six month long study. All men that agree to participate will allow the barber to measure their blood pressure each time they return to Wally's Barbershop for a haircut and ask their barber to call the study's pharmacist to arrange a follow-up visit in a local pharmacy. The goal of this second study is to show if a team approach, which means involvement of a barber and the pharmacist, can help make it easier for men to work with their doctor to get blood pressure under control.
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
- Hypertension
- Being tested
- barbershop-based BP measurement
- Keywords
- Hypertension, High Blood Pressure, African American Men, Black Men
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
barbershop-based BP measurementOther
Also called BP measurenents at their barbershop & BP reducing medication
BP Measurements and blood pressure reducing medication
| Study group | Role | What they receive |
|---|---|---|
| barbershop-based BP measurement | Other | BP monitoring by barbershop based Barbers and BP lowering medication(s) Receives: Other: barbershop-based BP measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Six-months
Secondary outcomes (1)
Health Questionnaire
interim health questionnaire will be administered to collect follow-up data and evaluate progress of participation
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startAug 2009
- Primary completionJun 2013
- Study completionJul 2013
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 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)
- Responsible party
- Principal investigator, Ron Victor, Cedars-Sinai Medical Center
- Investigators
- Ronald Victor, MD, Principal investigator, Cedars-Sinai Medical CenterJeffery Wilkins, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198144
- Sponsor's protocol ID
- BARBER-1
- Other IDs
- R01HL080582
- Status last verified
- Jul 2014
- First submitted
- 12 May 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20975012Rader 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, 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 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barber-Based Intervention for Hypertension in Black Men: Follow-Up Evaluation
- ClinicalTrials.gov ID
- NCT02198144
- Acronym / sponsor ID
- BARBER-1
- Conditions
- Hypertension
- Keywords
- Hypertension, High Blood Pressure, African American Men, Black Men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Jul 2014 (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.
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.
Detailed description
This study is the second of two "Barbershop" studies at Cedars-Sinai Medical Center. The first study at Wally's Barbershop in Altadena, CA was called the "Barber-Based Intervention for Hypertension in Black Men: Baseline Data Collection." Men at Wally's barbershop who were found to have high blood pressure as a participant in the first study are now being asked to participate in the second Cedars-Sinai study. During this second study the men will be asked to (1) return to Wally's barbershop to have their blood pressure measured to see how they are doing now, (2) review any medicines participants are taking, and (3) work with a health care team that includes their doctor, personal barber, and a pharmacist, to help them improve their blood pressure management. This second study is a six month long study. All men that agree to participate will allow the barber to measure their blood pressure each time they return to Wally's Barbershop for a haircut and ask their barber to call the study's pharmacist to arrange a follow-up visit in a local pharmacy. The goal of this second study is to show if a team approach, which means involvement of a barber and the pharmacist, can help make it easier for men to work with their doctor to get blood pressure under control.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| barbershop-based BP measurement | Other | Other: barbershop-based BP measurementBP monitoring by barbershop based Barbers and BP lowering medication(s) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18 years of age or older) African-American male
- Regular (unsolicited) customer of this barbershop.
- There is no upper age limit
Key exclusion criteria (6 listed)
- Self-assigned race/ethnicity other than African-American/ non-Hispanic black
- Female gender
- Age < 18
- Language other than 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 |
|---|---|---|
| barbershop-based BP measurementAlso: BP measurenents at their barbershop & BP reducing medicationBP Measurements and blood pressure reducing medication | Other | barbershop-based BP measurement |
Primary outcome
out-of-office blood pressure
Time frame: Six-months
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).
1 secondary outcome
Health Questionnaire
Time frame: Six 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 23 Jul 2014.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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 Victor, MD principal investigator
Cedars-Sinai Medical Center
Jeffery Wilkins, MD principal investigator
Cedars-Sinai 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 barbershop-based BP measurement 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 3 inclusion and 6 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 23 Jul 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?
out-of-office blood pressure (time frame: Six-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 NCT02198144, 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 23 Jul 2014.