<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/NCT03017092</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1442</org_study_id>
    <secondary_id>1R35CA197573-01</secondary_id>
    <secondary_id>A534252</secondary_id>
    <secondary_id>SMPH\MEDICINE\TOBACCO RE</secondary_id>
    <nct_id>NCT03017092</nct_id>
  </id_info>
  <brief_title>Tobacco Pilot Study for Low Income Smokers</brief_title>
  <official_title>Tobacco Pilot Study for Low Income Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study to test feasibility of delivering a motivational smoking cessation intervention&#xD;
      to low income smokers via a computer tablet.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Twenty Salvation Army clients will be recruited to pilot test a motivational smoking&#xD;
      cessation counseling intervention that is delivered via a tablet computer. Study participants&#xD;
      will be given brief instructions on how to use the tablet. They will then complete a brief&#xD;
      survey on the tablet. This will be followed by the researcher using the tablet to provide the&#xD;
      motivational intervention. Finally, study participants will be interviewed to establish this&#xD;
      perceptions of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">January 27, 2017</completion_date>
  <primary_completion_date type="Actual">January 27, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ease of use of tablet-guided tobacco intervention assessed by interview and summarized across study participants</measure>
    <time_frame>Immediately after exposure to intervention</time_frame>
    <description>At the end of the intervention, each study participant will be interviewed regarding how easy the tablet computer was to use. This qualitative information will by summarized across all study participants.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>tablet-guided</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants will be administered a brief tobacco intervention by a Salvation Army staff person who is guided by a tablet computer</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tablet-guided tobacco intervention</intervention_name>
    <description>This intervention, as guided by a tablet computer, is a brief (20 minute) counseling intervention designed to increase motivation to quit smoking and to increase knowledge of methods of quitting.</description>
    <arm_group_label>tablet-guided</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  current smoker (≥ 10 cigarettes/week for the past six months who are not currently&#xD;
             trying to quit)&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  English speaking/writing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not receiving services for the Salvation Army&#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>
  <location>
    <facility>
      <name>University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>December 23, 2019</last_update_submitted>
  <last_update_submitted_qc>December 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</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/NCT03017092
org study id: 2016-1442
secondary id: 1R35CA197573-01
secondary id: A534252
secondary id: SMPH\MEDICINE\TOBACCO RE
nct id: NCT03017092
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pilot study to test feasibility of delivering a motivational smoking cessation intervention
      to low income smokers via a computer tablet.
Twenty Salvation Army clients will be recruited to pilot test a motivational smoking
      cessation counseling intervention that is delivered via a tablet computer. Study participants
      will be given brief instructions on how to use the tablet. They will then complete a brief
      survey on the tablet. This will be followed by the researcher using the tablet to provide the
      motivational intervention. Finally, study participants will be interviewed to establish this
      perceptions of the intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Ease of use of tablet-guided tobacco intervention assessed by interview and summarized across study participants
time frame: Immediately after exposure to intervention
description: At the end of the intervention, each study participant will be interviewed regarding how easy the tablet computer was to use. This qualitative information will by summarized across all study participants.
arm group label: tablet-guided
arm group type: Experimental
description: Study participants will be administered a brief tobacco intervention by a Salvation Army staff person who is guided by a tablet computer
intervention type: Behavioral
intervention name: Tablet-guided tobacco intervention
description: This intervention, as guided by a tablet computer, is a brief (20 minute) counseling intervention designed to increase motivation to quit smoking and to increase knowledge of methods of quitting.
arm group label: tablet-guided
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder