<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/NCT03020836</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00089710</org_study_id>
    <nct_id>NCT03020836</nct_id>
  </id_info>
  <brief_title>Evaluating Effective Methods for Referral for Smoking Cessation Counseling and High Blood Pressure Follow-up</brief_title>
  <official_title>Evaluating Effective Methods for Referral for Smoking Cessation Counseling and High Blood Pressure Follow-up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Investigators conducted a clinic-based study to determine the magnitude of uncontrolled&#xD;
      hypertension and current smoking in eye doctor's offices and sought to determine if referral&#xD;
      to care results in actions taken by the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking and hypertension are two modifiable risk factors that are linked to highly prevalent&#xD;
      chronic diseases such as diabetes and cardiovascular disease. The ophthalmology waiting room&#xD;
      has the potential to be an effective point of intervention to provide referral to primary&#xD;
      care in addition to health education on preventive health topics.&#xD;
&#xD;
      The investigators therefore, conducted a clinic-based study to determine the magnitude of&#xD;
      uncontrolled hypertension and current smoking in eye doctor's offices and to determine if&#xD;
      referral to care results in actions taken by the patient.&#xD;
&#xD;
      The investigators determined the proportion of patients who have elevated blood pressure.&#xD;
      Patients were referred appropriately and the proportion of participants who followed the&#xD;
      recommendation to meet with their primary care doctor for elevated blood pressure at 4-6&#xD;
      weeks and 8-10 weeks was determined. In addition, those who consented to be in the study and&#xD;
      admitted to smoking cigarettes were offered smoking cessation assistance through a quit line.&#xD;
      Investigators also followed up on cigarette smoking at 4-6 weeks and 8-10 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients with elevated blood pressure</measure>
    <time_frame>1 day (at study clinic visit)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that are current smokers</measure>
    <time_frame>1 day (at study clinic visit)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with elevated blood pressure that sought referral care</measure>
    <time_frame>From study visit to 10 weeks after</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that were current smokers that sought referral quit line assistance</measure>
    <time_frame>From study visit to 10 weeks after</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">473</enrollment>
  <condition>Hypertension</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Hypertension patient referral</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Referral to primary care physician for hypertension control: Patients with uncontrolled hypertension were referred to a primary care physician for treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smoking cessation patient referral</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Referral to smoking quit line: Patients that were current smokers were referred to the Maryland smoking cessation quit line if they were willing.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Referral to primary care physician for hypertension control</intervention_name>
    <description>Referral to primary care physician for hypertension control</description>
    <arm_group_label>Hypertension patient referral</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Referral to smoking quit line</intervention_name>
    <description>Referral to Maryland Tobacco/Smoking quit line for help with smoking cessation</description>
    <arm_group_label>Smoking cessation patient referral</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients &gt;18 years of age presenting to the glaucoma service and general eye service&#xD;
             at Wilmer Eye Institute.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers&#xD;
&#xD;
          -  Unable to provide written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johns Hopkins University</investigator_affiliation>
    <investigator_full_name>David S. Friedman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03020836
org study id: NA_00089710
nct id: NCT03020836
lead sponsor: 
has dmc: No
Investigators conducted a clinic-based study to determine the magnitude of uncontrolled
      hypertension and current smoking in eye doctor's offices and sought to determine if referral
      to care results in actions taken by the patient.
Smoking and hypertension are two modifiable risk factors that are linked to highly prevalent
      chronic diseases such as diabetes and cardiovascular disease. The ophthalmology waiting room
      has the potential to be an effective point of intervention to provide referral to primary
      care in addition to health education on preventive health topics.

      The investigators therefore, conducted a clinic-based study to determine the magnitude of
      uncontrolled hypertension and current smoking in eye doctor's offices and to determine if
      referral to care results in actions taken by the patient.

      The investigators determined the proportion of patients who have elevated blood pressure.
      Patients were referred appropriately and the proportion of participants who followed the
      recommendation to meet with their primary care doctor for elevated blood pressure at 4-6
      weeks and 8-10 weeks was determined. In addition, those who consented to be in the study and
      admitted to smoking cigarettes were offered smoking cessation assistance through a quit line.
      Investigators also followed up on cigarette smoking at 4-6 weeks and 8-10 weeks.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Proportion of patients with elevated blood pressure
time frame: 1 day (at study clinic visit)
measure: Proportion of patients that are current smokers
time frame: 1 day (at study clinic visit)
measure: Proportion of patients with elevated blood pressure that sought referral care
time frame: From study visit to 10 weeks after
measure: Proportion of patients that were current smokers that sought referral quit line assistance
time frame: From study visit to 10 weeks after
arm group label: Hypertension patient referral
arm group type: Other
description: Referral to primary care physician for hypertension control: Patients with uncontrolled hypertension were referred to a primary care physician for treatment.
arm group label: Smoking cessation patient referral
arm group type: Other
description: Referral to smoking quit line: Patients that were current smokers were referred to the Maryland smoking cessation quit line if they were willing.
intervention type: Behavioral
intervention name: Referral to primary care physician for hypertension control
description: Referral to primary care physician for hypertension control
arm group label: Hypertension patient referral
intervention type: Behavioral
intervention name: Referral to smoking quit line
description: Referral to Maryland Tobacco/Smoking quit line for help with smoking cessation
arm group label: Smoking cessation patient referral
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Johns Hopkins University
investigator full name: David S. Friedman
investigator title: Professor
mesh term: Hypertension
sharing ipd: No