<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02198144</url>
  </required_header>
  <id_info>
    <org_study_id>BARBER-1</org_study_id>
    <secondary_id>R01HL080582</secondary_id>
    <nct_id>NCT02198144</nct_id>
  </id_info>
  <brief_title>Cut Your Pressure Too: The Altadena Barbershop Blood Pressure Study, Phase 2 (Intervention Pilot Study)</brief_title>
  <official_title>Barber-Based Intervention for Hypertension in Black Men: Follow-Up Evaluation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      African American men have the highest risk of any group for early death &amp; disability from&#xD;
      high blood pressure (BP). Clinical investigations in Dallas, TX demonstrated that African&#xD;
      American men with high BP are able to improve their BPs when participants agree to have their&#xD;
      BP measured at their barbershop by their barber &amp; also take BP reducing medication as&#xD;
      instructed by a healthcare team that includes their doctor. The goal of this study is to&#xD;
      bring a barbershop-based model of BP measurement, treatment &amp; follow-up from Dallas, TX to&#xD;
      the Southern California area. This study is the 2nd of two &quot;Barbershop&quot; studies at&#xD;
      Cedars-Sinai Medical Center. The 1st study was called the &quot;Barber-Based Intervention for&#xD;
      Hypertension in Black Men: Baseline Data Collection.&quot; In this 2nd study at Wally's&#xD;
      barbershop, the Investigators will enlist pharmacists to integrate the community health&#xD;
      promotion program in barbershops into the healthcare system. Barbers are uniquely positioned&#xD;
      to facilitate hypertension case detection &amp; referral, pharmacists are uniquely positioned to&#xD;
      facilitate case management. Pharmacists have extensive knowledge of BP medication &amp; they have&#xD;
      earned the respect of patients and physicians alike. In this intervention study, barbers will&#xD;
      be trained to measure the BP &amp; refer those who have already been identified as having high BP&#xD;
      to a community pharmacist for confirmation of uncontrolled high BP &amp; development of a BP&#xD;
      management plan. The pharmacist will work with the customers' physicians to optimize the BP&#xD;
      medication prescribed &amp; with individual customers to provide a user-friendly &quot;medical home.&quot;&#xD;
      Pharmacists will improve the customer's access to state-of-the-art medical care, The data&#xD;
      from this study will be used to apply for a new NIH Grant. In addition, the summarized data&#xD;
      will be shared with key stakeholders in the local community (including barbers, patrons,&#xD;
      local healthcare providers, local pharmacists &amp; other community leaders) to design a larger&#xD;
      community-partnered intervention.&#xD;
&#xD;
      Specific Aims:&#xD;
&#xD;
      Aim 1. To evaluate the impact of the new intervention model on HTN control in African&#xD;
      American males.&#xD;
&#xD;
      Aim 2. To evaluate the cost-effectiveness of the new intervention. The investigators&#xD;
      hypothesize that the projected cost-savings to the healthcare system in reduced heart attack&#xD;
      &amp; stroke care will outweigh intervention &amp; medication costs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is the second of two &quot;Barbershop&quot; studies at Cedars-Sinai Medical Center. The&#xD;
      first study at Wally's Barbershop in Altadena, CA was called the &quot;Barber-Based Intervention&#xD;
      for Hypertension in Black Men: Baseline Data Collection.&quot; Men at Wally's barbershop who were&#xD;
      found to have high blood pressure as a participant in the first study are now being asked to&#xD;
      participate in the second Cedars-Sinai study. During this second study the men will be asked&#xD;
      to (1) return to Wally's barbershop to have their blood pressure measured to see how they are&#xD;
      doing now, (2) review any medicines participants are taking, and (3) work with a health care&#xD;
      team that includes their doctor, personal barber, and a pharmacist, to help them improve&#xD;
      their blood pressure management. This second study is a six month long study. All men that&#xD;
      agree to participate will allow the barber to measure their blood pressure each time they&#xD;
      return to Wally's Barbershop for a haircut and ask their barber to call the study's&#xD;
      pharmacist to arrange a follow-up visit in a local pharmacy. The goal of this second study is&#xD;
      to show if a team approach, which means involvement of a barber and the pharmacist, can help&#xD;
      make it easier for men to work with their doctor to get blood pressure under control.&#xD;
&#xD;
      ROLE MODEL STORIES (DEVELOPMENT OF HEALTH MESSAGING TOOLS) Role model posters are not&#xD;
      intended as recruitment materials, but rather are educational tools that intend to highlight&#xD;
      positive experiences of participation. The text of the role model stories will in no way&#xD;
      provide statements of the effectiveness of the intervention being evaluated by the present&#xD;
      research study. Rather, they are the main health messaging tools needed to promote completion&#xD;
      of the program in order to achieve the experiences described. Essentially they document will&#xD;
      be used as an intervention tool for peer-based health messaging - stories from real customers&#xD;
      in the barbershop modeling target behaviors leading that promote continued participation in&#xD;
      the protocol by peers with the hopes of achieving to the detection, treatment, and control of&#xD;
      high blood pressure. The Cedars-Sinai research team will interview selected participants who&#xD;
      are already adopters of our new program, to serve as models for their peers and write the&#xD;
      model stories that will be displayed in the barbershop. Each story will model one specific&#xD;
      behavior, one influencing factor, and one positive outcome. Each role model story will&#xD;
      encourage one of two desired health behaviors of potential subjects with elevated BP: 1) ask&#xD;
      the barber to check patients' BP with each haircut, 2) schedule a follow-up visit with the&#xD;
      study pharmacist to get patient's blood pressure under control. Large posters in the&#xD;
      barbershop will show the model customer, his barber, and the study pharmacist who facilitated&#xD;
      the desired behavior change. The model's (participants) own words will be used on the poster.&#xD;
      A signed memo of agreement will be obtained from each model to record and display their story&#xD;
      and anyone who is pictured in the story will also sign a memo of agreement to participate.&#xD;
      The model will approve the final draft of the poster before being displayed in the&#xD;
      barbershop, and control of high blood pressure. The Cedars-Sinai research team will interview&#xD;
      selected participants who are already adopters of our new program, to serve as models for&#xD;
      their peers and write the model stories that will be displayed in the barbershop. Each story&#xD;
      will model one specific behavior, one influencing factor, and one positive outcome. Each role&#xD;
      model story will encourage one of two desired health behaviors of potential subjects with&#xD;
      elevated BP: 1) ask the barber to check patient's BP with each haircut, 2) schedule a&#xD;
      follow-up visit with the study pharmacist to get patient's blood pressure under control.&#xD;
      Large posters in the barbershop will show the model customer, his barber, and the study&#xD;
      pharmacist who facilitated the desired behavior change. The model's (participants) own words&#xD;
      will be used on the poster. A signed memo of agreement will be obtained from each model to&#xD;
      record and display their story and anyone who is pictured in the story will also sign a memo&#xD;
      of agreement to participate. The model will approve the final draft of the poster before&#xD;
      being displayed in the barbershop.&#xD;
&#xD;
      AME11226: The investigators are requesting an amendment to our original protocol in order to&#xD;
      pilot test a six-month Minimal Maintenance Phase that will follow the six-month Intervention&#xD;
      Phase. The barber will continue to monitor participants' blood pressure but the study&#xD;
      pharmacists will limit their interaction to phone calls (vs. face-to-face visits as in the&#xD;
      Intervention Phase). In addition, all study compensation for participants will be&#xD;
      discontinued. The goal of discontinuing such compensation is to demonstrate that participants&#xD;
      will continue to be proactive about controlling their blood pressure as a result of intrinsic&#xD;
      motivation with continued social support from the barber and minimal phone follow-up with the&#xD;
      pharmacist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>out-of-office blood pressure</measure>
    <time_frame>Six-months</time_frame>
    <description>The six-month Intervention Phase is a final blood pressure reading by research staff in the barbershop, with a goal of &lt; 135/85 mmHg (the recommended goal for out-of-office blood pressure).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health Questionnaire</measure>
    <time_frame>Six Months</time_frame>
    <description>interim health questionnaire will be administered to collect follow-up data and evaluate progress of participation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>barbershop-based BP measurement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>BP monitoring by barbershop based Barbers and BP lowering medication(s)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>barbershop-based BP measurement</intervention_name>
    <description>BP Measurements and blood pressure reducing medication</description>
    <arm_group_label>barbershop-based BP measurement</arm_group_label>
    <other_name>BP measurenents at their barbershop &amp; BP reducing medication</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (18 years of age or older) African-American male&#xD;
&#xD;
          -  Regular (unsolicited) customer of this barbershop.&#xD;
&#xD;
          -  There is no upper age limit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Self-assigned race/ethnicity other than African-American/ non-Hispanic black&#xD;
&#xD;
          -  Female gender&#xD;
&#xD;
               -  In barbershops that cater to African-American men, approximately 2% of the&#xD;
                  clientele are women. The female customers will not be surveyed but may be offered&#xD;
                  a free blood pressure screening.&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
               -  Children will not be surveyed because the prevalence of the condition being&#xD;
                  studied (hypertension) is low and does not justify the added logistical&#xD;
                  difficulties in obtaining informed consent. Although the population surveyed will&#xD;
                  be restricted to adult black men, the barbershop provides an excellent setting to&#xD;
                  foster blood pressure screening in children and adolescents who comprise 15-20%&#xD;
                  of the barbershop clientele. During the study period, staff may offer blood&#xD;
                  pressure screening to all children accompanied by a parent and to all&#xD;
                  adolescents.&#xD;
&#xD;
          -  Language other than English&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronald Victor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffery Wilkins, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinail Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>20975012</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>23978276</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>19081393</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>May 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Ron Victor</investigator_full_name>
    <investigator_title>Director, Hypertension Center of Excellence</investigator_title>
  </responsible_party>
  <keyword>Hypertension</keyword>
  <keyword>High Blood Pressure</keyword>
  <keyword>African American Men</keyword>
  <keyword>Black Men</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02198144
org study id: BARBER-1
secondary id: R01HL080582
nct id: NCT02198144
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: out-of-office blood pressure
time frame: Six-months
description: 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).
measure: Health Questionnaire
time frame: Six Months
description: interim health questionnaire will be administered to collect follow-up data and evaluate progress of participation
arm group label: barbershop-based BP measurement
arm group type: Other
description: BP monitoring by barbershop based Barbers and BP lowering medication(s)
intervention type: Other
intervention name: barbershop-based BP measurement
description: BP Measurements and blood pressure reducing medication
arm group label: barbershop-based BP measurement
other name: BP measurenents at their barbershop & BP reducing medication
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ronald Victor, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Jeffery Wilkins, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
facility: 
country: United States
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Ron Victor
investigator title: Director, Hypertension Center of Excellence
mesh term: Hypertension