<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/NCT02986711</url>
  </required_header>
  <id_info>
    <org_study_id>40683</org_study_id>
    <nct_id>NCT02986711</nct_id>
  </id_info>
  <brief_title>Penn State TXT2STAYQUIT Study- a Texting Study to Help Hospitalized Smokers Stay Quit</brief_title>
  <official_title>Pilot Randomized Trial of Brief Automated Smoking Cessation Intervention and Evaluation for Smokers Discharged From Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Milton S. Hershey Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to pilot a method of collecting the post-discharge follow-up data required by&#xD;
      the Joint Commission Tobacco Measure Set, using text messages sent to and received from&#xD;
      patients' cellular-telephones. It also aims to assess whether specially designed relapse&#xD;
      prevention text messages designed to encourage abstinence from smoking, can increase the&#xD;
      proportion of smokers who remain abstinent during the first month after discharge from&#xD;
      hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be those who are hospitalized at Hershey Medical Center and are interested&#xD;
      in help to stay quit when they leave the hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding exhausted&#xD;
  </why_stopped>
  <start_date>December 2013</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide &lt; 10 Parts Per Million).</measure>
    <time_frame>28 days</time_frame>
    <description>Abstinence rate at 28 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Providing Smoking Cessation Status Via Text Message</measure>
    <time_frame>28 days</time_frame>
    <description>proportion of participants providing data about smoking status via text message at 28 days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Nicotine Dependence, Cigarettes</condition>
  <arm_group>
    <arm_group_label>Motivational Text Messages</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Motivational text messages to help participants stay quit when they leave the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Text messages to ask about current smoking status.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational Text Messages</intervention_name>
    <description>Motivational text messages in addition to survey questions about smoking status</description>
    <arm_group_label>Motivational Text Messages</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Only survey questions about smoking status</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total length of hospital stay at least 24 hours&#xD;
&#xD;
          -  Free of cognitive impairment&#xD;
&#xD;
          -  Read and speak English&#xD;
&#xD;
          -  Smoked at least 20 cigarettes in 30 days prior to entering the hospital&#xD;
&#xD;
          -  Willing to give up all forms of tobacco&#xD;
&#xD;
          -  Has a cell phone capable of receiving text messages (cell phone is powered on and&#xD;
             charged)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has been admitted for a transplant&#xD;
&#xD;
          -  Patient has Intensive Care status&#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>
  <overall_official>
    <last_name>Jonathan Foulds, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Penn State College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 8, 2015</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <results_first_submitted>January 11, 2018</results_first_submitted>
  <results_first_submitted_qc>January 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">September 21, 2018</results_first_posted>
  <last_update_submitted>December 17, 2018</last_update_submitted>
  <last_update_submitted_qc>December 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Jonathan Foulds</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>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Motivational Text Messages</title>
          <description>Motivational text messages to help participants stay quit when they leave the hospital.&#xD;
Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Text messages to ask about current smoking status.&#xD;
Control: Only survey questions about smoking status</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="70"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Motivational Text Messages</title>
          <description>Motivational text messages to help participants stay quit when they leave the hospital.&#xD;
Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Text messages to ask about current smoking status.&#xD;
Control: Only survey questions about smoking status</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="70"/>
            <count group_id="B2" value="70"/>
            <count group_id="B3" value="140"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.1" spread="13.3"/>
                    <measurement group_id="B2" value="42.5" spread="13.3"/>
                    <measurement group_id="B3" value="41.8" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide &lt; 10 Parts Per Million).</title>
        <description>Abstinence rate at 28 days</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Motivational Text Messages</title>
            <description>Motivational text messages to help participants stay quit when they leave the hospital.&#xD;
Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Text messages to ask about current smoking status.&#xD;
Control: Only survey questions about smoking status</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide &lt; 10 Parts Per Million).</title>
          <description>Abstinence rate at 28 days</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Participants Providing Smoking Cessation Status Via Text Message</title>
        <description>proportion of participants providing data about smoking status via text message at 28 days</description>
        <time_frame>28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Motivational Text Messages</title>
            <description>Motivational text messages to help participants stay quit when they leave the hospital.&#xD;
Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Text messages to ask about current smoking status.&#xD;
Control: Only survey questions about smoking status</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Participants Providing Smoking Cessation Status Via Text Message</title>
          <description>proportion of participants providing data about smoking status via text message at 28 days</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="70"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Motivational Text Messages</title>
          <description>Motivational text messages to help participants stay quit when they leave the hospital.&#xD;
Motivational Text Messages: Motivational text messages in addition to survey questions about smoking status</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Text messages to ask about current smoking status.&#xD;
Control: Only survey questions about smoking status</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="70"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jessica Yingst</name_or_title>
      <organization>Penn State University College of Medicine</organization>
      <phone>7175310003 ext 289511</phone>
      <email>jmy5048@psu.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02986711
org study id: 40683
nct id: NCT02986711
lead sponsor: 
has dmc: No
This study aims to pilot a method of collecting the post-discharge follow-up data required by
      the Joint Commission Tobacco Measure Set, using text messages sent to and received from
      patients' cellular-telephones. It also aims to assess whether specially designed relapse
      prevention text messages designed to encourage abstinence from smoking, can increase the
      proportion of smokers who remain abstinent during the first month after discharge from
      hospital.
Participants will be those who are hospitalized at Hershey Medical Center and are interested
      in help to stay quit when they leave the hospital.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Complete Self-reported Tobacco Abstinence During the Prior 7 Days, as Reported on Telephone Interview, 28 Days After Discharge From Hospital (With Biochemical Verification in a Sub-sample, Exhaled Carbon-monoxide < 10 Parts Per Million).
time frame: 28 days
description: Abstinence rate at 28 days
measure: Proportion of Participants Providing Smoking Cessation Status Via Text Message
time frame: 28 days
description: proportion of participants providing data about smoking status via text message at 28 days
arm group label: Motivational Text Messages
arm group type: Experimental
description: Motivational text messages to help participants stay quit when they leave the hospital.
arm group label: Control
arm group type: Sham Comparator
description: Text messages to ask about current smoking status.
intervention type: Behavioral
intervention name: Motivational Text Messages
description: Motivational text messages in addition to survey questions about smoking status
arm group label: Motivational Text Messages
intervention type: Behavioral
intervention name: Control
description: Only survey questions about smoking status
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathan Foulds, PhD
role: Principal Investigator
affiliation: Penn State College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Jonathan Foulds
investigator title: Professor
mesh term: Tobacco Use Disorder
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 