HypertensionNCT02321618
Cut Your Pressure Too: The Los Angeles Barbershop Blood Pressure Study
A study testing BP measurement & pharmacy and BP educational materials in people with Hypertension, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 79 years, men only
- Conditions the study is for
- Hypertension
- What is being tested?
- BP measurement & pharmacy and BP educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2015to 9 Jan 2018
- 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 35 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women
- Children
- <35 years of age
- Non-black
- Hispanic ethnicity
- New/infrequent patronage (<8 haircuts at same barbershop in last 12 months)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Barber-Pharmacist Coordination to Improve Blood Pressure Management in Black Men
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- BP measurement & pharmacy, BP educational materials
- Keywords
- Hypertension, High Blood Pressure, African American men, Black men, barbershop
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP measurement & pharmacyBehavioural
Blood pressure monitoring by barber, blood pressure medication management by pharmacist, role model posters encouraging program participation
BP educational materialsBehavioural
Exposure to hypertension educational materials
| Study group | Role | What they receive |
|---|---|---|
| BP measurement & pharmacy | Experimental | BP measurements performed by barber, role model poster exposure in barbershop, and BP medication management visits with study pharmacist Receives: Behavioral: BP measurement & pharmacy |
| BP educational materials | Other | Exposure to hypertension educational materials in barbershop Receives: Behavioral: BP educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Blood Pressure Outcome - change in systolic blood pressure
The pre-specified primary outcome was the change in systolic blood pressure from baseline to 6 months follow-up.
Measured: 6 months
Secondary outcomes (6)
Secondary Blood Pressure Outcome - change in diastolic blood pressure
The change in diastolic blood pressure from baseline to 6 month follow-up
Measured: 6 months
The percentage of participants achieving blood pressure goal
The percentage of participants who achieved blood pressure goal after 6 months follow-up (140/90,135/85, 130/80)
Measured: 6 months
The change in number/type of drug classes prescribed
The change in number/class of prescription drugs prescribed from baseline to 6 month follow-up
Measured: 6 months
Adverse Drug Reactions
The number and type of adverse drug reactions reported from baseline to 6 month follow-up
Measured: 6 months
Self-Rated Health
The change in self-rated health score from baseline to 6 month follow-up
Measured: 6 months
Self-Rated Patient Engagement
The change in PACIC patient engagement score from baseline to 6 month follow-up
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study start17 Feb 2015
- Primary completion30 Jun 2017
- Study completion9 Jan 2018
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), The California Endowment, University of California, Los Angeles, Lincy Foundation
- Responsible party
- Principal investigator, Ron Victor, Cedars-Sinai Medical Center
- Investigators
- Ronald G Victor, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321618
- Sponsor's protocol ID
- Pro00035347
- Other IDs
- 5R01HL117983-02
- Status last verified
- Jul 2018
- First submitted
- 17 Dec 2014
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 30827133Victor 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.
PubMed 30592662Victor 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.
PubMed 29527973
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barber-Pharmacist Coordination to Improve Blood Pressure Management in Black Men
- ClinicalTrials.gov ID
- NCT02321618
- Acronym / sponsor ID
- Pro00035347
- Conditions
- Hypertension
- Keywords
- Hypertension, High Blood Pressure, African American men, Black men, barbershop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), The California Endowment, University of California, Los Angeles, Lincy Foundation
- Study start
- 17 Feb 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 9 Jan 2018 (actual)
- First posted
- 22 Dec 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP measurement & pharmacy | Experimental | Behavioral: BP measurement & pharmacyBP measurements performed by barber, role model poster exposure in barbershop, and BP medication management visits with study pharmacist |
| BP educational materials | Other | Behavioral: BP educational materialsExposure to hypertension educational materials in barbershop |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Women
- Children
- <35 years of age
- Non-black
- Hispanic ethnicity
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 |
|---|---|---|
| BP measurement & pharmacyBlood pressure monitoring by barber, blood pressure medication management by pharmacist, role model posters encouraging program participation | Behavioural | BP measurement & pharmacy |
| BP educational materialsExposure to hypertension educational materials | Behavioural | BP educational materials |
Primary outcome
Primary Blood Pressure Outcome - change in systolic blood pressure
Time frame: 6 months
The pre-specified primary outcome was the change in systolic blood pressure from baseline to 6 months follow-up.
6 secondary outcomes
Secondary Blood Pressure Outcome - change in diastolic blood pressure
Time frame: 6 months
The percentage of participants achieving blood pressure goal
Time frame: 6 months
The change in number/type of drug classes prescribed
Time frame: 6 months
Adverse Drug Reactions
Time frame: 6 months
Self-Rated Health
Time frame: 6 months
Self-Rated Patient Engagement
Time frame: 6 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 10 Jul 2018.
- Derived from this study: PubMed 30827133Victor 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.
- Derived from this study: PubMed 30592662Victor 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.
- Derived from this study: PubMed 29527973Victor 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.
- Individual participant dataSharing planned: Undecided
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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
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 BP measurement & pharmacy and BP educational materials 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 5 inclusion and 12 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 10 Jul 2018. 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?
Primary Blood Pressure Outcome - change in systolic blood pressure (time frame: 6 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 NCT02321618, 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 10 Jul 2018.