<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/NCT03295643</url>
  </required_header>
  <id_info>
    <org_study_id>C-601</org_study_id>
    <nct_id>NCT03295643</nct_id>
  </id_info>
  <brief_title>Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months</brief_title>
  <official_title>Outcomes From a Mobile Smoking Cessation Program During a Monitoring Period of 6 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jennifer Marler, MD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pivot Health Technologies Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, open label, single center clinical study enrolling 260 subjects in a mobile&#xD;
      smoking cessation program using a smartphone app and a handheld breath sensor with coaching&#xD;
      support over a six month period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, open label, single center clinical study enrolling 260 subjects in a&#xD;
      mobile smoking cessation program using a smartphone app and handheld breath sensor with&#xD;
      coaching support over a six month period. Measurements include user engagement and retention&#xD;
      in the program, attitude towards smoking and smoking behavior, quit rates, relapse rates, and&#xD;
      quality of life over the study period, as well as user feedback on the program.&#xD;
&#xD;
      Potential participants will complete an online screening form. Eligible participants will be&#xD;
      called to confirm eligibility, discuss the study, and have their questions about the study&#xD;
      answered. Interested eligible participants will then be emailed the registration link, which&#xD;
      includes the electronic informed consent. After providing electronic informed consent,&#xD;
      subjects register online and receive the hand held device which measures carbon monoxide (CO)&#xD;
      which correlates to smoking behavior.&#xD;
&#xD;
      Baseline questionnaires (demographics, smoking history, and attitude towards smoking) are&#xD;
      completed, and subjects then self-train to use the breath sensor and smartphone app and&#xD;
      allows viewing of CO sample values. The app also provides the user with ability to log&#xD;
      cigarettes, view cigarette consumption trends, view instructional videos, complete&#xD;
      educational activities and challenges, and engage with a coach.&#xD;
&#xD;
      Participants will experience the program in 5 phases and then complete the study at&#xD;
      approximately six months after enrolling,activating device and app.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>
    <intervention_model_description>All subjects experience same program</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Completed the Explore Stage</measure>
    <time_frame>Assessment at the end of the Explore stage; 9 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
    <description>For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Completed the Build Stage</measure>
    <time_frame>Assessment at the end of the Build stage; between 10 and 37 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
    <description>For the number of participants who started the Build Stage, the proportion who completed the Build Stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Completed the Mobilize Stage</measure>
    <time_frame>Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
    <description>For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Completed the Quit Stage</measure>
    <time_frame>Assessment at the end of the Quit Stage; between 24 and 51 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days.</time_frame>
    <description>For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Completed the Secure Stage</measure>
    <time_frame>Assessment at the end of the Secure Stage; between 101 and 128 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.</time_frame>
    <description>For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Readiness to Quit and Goals Related to Smoking Behavior</measure>
    <time_frame>Assessment at the end of the Explore stage; 9 days after activating app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
    <description>Are you seriously thinking of quitting smoking? (stage of change) &quot;Yes, within the next 30 days&quot;. &quot;Yes, within the next 6 months&quot;. &quot;No, not thinking of quitting&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage</measure>
    <time_frame>Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
    <description>Average percentage change in cigarettes per day (CPD) by the Pre-Quit Stage using repeated measures linear mixed model analysis.&#xD;
Model uses all available data on CPD to estimate an average. The Pre-Quit Stage is defined as from the start of the study (activation of the app and device/ Baseline) to the end of the Mobilize Stage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weeks of Active Engagement</measure>
    <time_frame>6 months</time_frame>
    <description>Engagement defined as interaction with the program at least once within app (app open, daily check-in, responds to coach, logs cigarettes, etc)&#xD;
Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Completed the Program</measure>
    <time_frame>6 months</time_frame>
    <description>The number of participants who completed the quit-smoking program.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quit Attempts</measure>
    <time_frame>6 months</time_frame>
    <description>Number attempt to quit by participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quit Rate 7-day Point Prevalence</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participant who have not smoked in last 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quit Rate 30-day Point Prevalence</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participant who have not smoked in last 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking</measure>
    <time_frame>6 months</time_frame>
    <description>the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Confidence to Quit</measure>
    <time_frame>Assessment at the end of the Mobilize Stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
    <description>Confidence to quit. Estimate of means and standard errors based on linear mixed model.&#xD;
Participants were asked: &quot;If you were to quit smoking right now, how successful would you be?&quot; Answered on a scale from 1 to 10 (1=not at all successful, 10=completely successful).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty Maintaining Quit</measure>
    <time_frame>Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
    <description>Difficulty maintaining quit. Estimate of means and standard errors based on linear mixed model.&#xD;
Participants were asked: &quot;If you were to quit smoking right now, how difficult do you think it would be to stay smoke-free?&quot; Answered on a scale from 1 to 10 (1=really hard to stay quit, 10=really easy to stay quit).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Mobile smoking cessation program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mobile smoking cessation program and CO breath sensor device</intervention_name>
    <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
    <arm_group_label>Mobile smoking cessation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Smokes daily&#xD;
&#xD;
          -  Smokes 5 or more cigarettes per day&#xD;
&#xD;
          -  Owns and uses a smartphone (iPhone 5 and above, operating system iOS 9.0 and above,&#xD;
             or, Android 4.4 and above, operating system Android 4.4 and above)&#xD;
&#xD;
          -  Employed at least 20 hours per week&#xD;
&#xD;
          -  Lives in the USA&#xD;
&#xD;
          -  Understands and willing to sign the Informed Consent Form&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Utley</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pivot Health Technologies Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carrot Inc.</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <results_first_submitted>September 15, 2022</results_first_submitted>
  <results_first_submitted_qc>October 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 10, 2022</results_first_posted>
  <last_update_submitted>October 17, 2022</last_update_submitted>
  <last_update_submitted_qc>October 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Pivot Health Technologies Inc.</investigator_affiliation>
    <investigator_full_name>Jennifer Marler, MD</investigator_full_name>
    <investigator_title>Senior Director, Clinical and Medical Affairs</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03295643/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Online recruitment</recruitment_details>
      <pre_assignment_details>Phone call to confirm eligibility.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mobile Smoking Cessation Program</title>
          <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
The mobile smoking cessation program includes 5 phases with the following names and timelines:&#xD;
Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="319"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Explore Stage</title>
              <participants_list>
                <participants group_id="P1" count="283"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Build Stage</title>
              <participants_list>
                <participants group_id="P1" count="183"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Mobilize Stage</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Quit Stage</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Secure Stage</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="272"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mobile Smoking Cessation Program</title>
          <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="319"/>
          </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="42.8" spread="10.2"/>
                  </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="184"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="264"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="319"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes smoked per day</title>
          <units>Cigarettes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.7" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the Explore Stage</title>
        <description>For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.</description>
        <time_frame>Assessment at the end of the Explore stage; 9 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Explore Stage</title>
          <description>For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.</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="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="283"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the Build Stage</title>
        <description>For the number of participants who started the Build Stage, the proportion who completed the Build Stage.</description>
        <time_frame>Assessment at the end of the Build stage; between 10 and 37 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Build Stage</title>
          <description>For the number of participants who started the Build Stage, the proportion who completed the Build Stage.</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="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the Mobilize Stage</title>
        <description>For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.</description>
        <time_frame>Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Mobilize Stage</title>
          <description>For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.</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="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the Quit Stage</title>
        <description>For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.</description>
        <time_frame>Assessment at the end of the Quit Stage; between 24 and 51 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Quit Stage</title>
          <description>For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.</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="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Completed the Secure Stage</title>
        <description>For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.</description>
        <time_frame>Assessment at the end of the Secure Stage; between 101 and 128 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Secure Stage</title>
          <description>For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.</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="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Readiness to Quit and Goals Related to Smoking Behavior</title>
        <description>Are you seriously thinking of quitting smoking? (stage of change) &quot;Yes, within the next 30 days&quot;. &quot;Yes, within the next 6 months&quot;. &quot;No, not thinking of quitting&quot;.</description>
        <time_frame>Assessment at the end of the Explore stage; 9 days after activating app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
        <population>Participants who provided baseline and explore stage results</population>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Readiness to Quit and Goals Related to Smoking Behavior</title>
          <description>Are you seriously thinking of quitting smoking? (stage of change) &quot;Yes, within the next 30 days&quot;. &quot;Yes, within the next 6 months&quot;. &quot;No, not thinking of quitting&quot;.</description>
          <population>Participants who provided baseline and explore stage results</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="281"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline - Stage of Change</title>
              <category_list>
                <category>
                  <title>Yes, within the next 30 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes, within the next 6 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="176"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No, not thinking of quitting</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Explore Stage - Stage of Change</title>
              <category_list>
                <category>
                  <title>Yes, within the next 30 days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes, within the next 6 months</title>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No, not thinking of quitting</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage</title>
        <description>Average percentage change in cigarettes per day (CPD) by the Pre-Quit Stage using repeated measures linear mixed model analysis.&#xD;
Model uses all available data on CPD to estimate an average. The Pre-Quit Stage is defined as from the start of the study (activation of the app and device/ Baseline) to the end of the Mobilize Stage.</description>
        <time_frame>Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage</title>
          <description>Average percentage change in cigarettes per day (CPD) by the Pre-Quit Stage using repeated measures linear mixed model analysis.&#xD;
Model uses all available data on CPD to estimate an average. The Pre-Quit Stage is defined as from the start of the study (activation of the app and device/ Baseline) to the end of the Mobilize Stage.</description>
          <units>percentage change in cpd</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.5" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weeks of Active Engagement</title>
        <description>Engagement defined as interaction with the program at least once within app (app open, daily check-in, responds to coach, logs cigarettes, etc)&#xD;
Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Weeks of Active Engagement</title>
          <description>Engagement defined as interaction with the program at least once within app (app open, daily check-in, responds to coach, logs cigarettes, etc)&#xD;
Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.4" spread="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Completed the Program</title>
        <description>The number of participants who completed the quit-smoking program.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Completed the Program</title>
          <description>The number of participants who completed the quit-smoking program.</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="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quit Attempts</title>
        <description>Number attempt to quit by participant</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Quit Attempts</title>
          <description>Number attempt to quit by participant</description>
          <units>quit attempts</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quit Rate 7-day Point Prevalence</title>
        <description>Number of participant who have not smoked in last 7 days</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Quit Rate 7-day Point Prevalence</title>
          <description>Number of participant who have not smoked in last 7 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="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quit Rate 30-day Point Prevalence</title>
        <description>Number of participant who have not smoked in last 30 days</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Quit Rate 30-day Point Prevalence</title>
          <description>Number of participant who have not smoked in last 30 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="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking</title>
        <description>the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking</title>
          <description>the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking</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="272"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Confidence to Quit</title>
        <description>Confidence to quit. Estimate of means and standard errors based on linear mixed model.&#xD;
Participants were asked: &quot;If you were to quit smoking right now, how successful would you be?&quot; Answered on a scale from 1 to 10 (1=not at all successful, 10=completely successful).</description>
        <time_frame>Assessment at the end of the Mobilize Stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Confidence to Quit</title>
          <description>Confidence to quit. Estimate of means and standard errors based on linear mixed model.&#xD;
Participants were asked: &quot;If you were to quit smoking right now, how successful would you be?&quot; Answered on a scale from 1 to 10 (1=not at all successful, 10=completely successful).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Confidence to Quit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="0.1443"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Explore Confidence to Quit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="0.1508"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Build Confidence to Quit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="0.1782"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Mobilize Confidence to Quit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="0.1916"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difficulty Maintaining Quit</title>
        <description>Difficulty maintaining quit. Estimate of means and standard errors based on linear mixed model.&#xD;
Participants were asked: &quot;If you were to quit smoking right now, how difficult do you think it would be to stay smoke-free?&quot; Answered on a scale from 1 to 10 (1=really hard to stay quit, 10=really easy to stay quit).</description>
        <time_frame>Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mobile Smoking Cessation Program</title>
            <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</description>
          </group>
        </group_list>
        <measure>
          <title>Difficulty Maintaining Quit</title>
          <description>Difficulty maintaining quit. Estimate of means and standard errors based on linear mixed model.&#xD;
Participants were asked: &quot;If you were to quit smoking right now, how difficult do you think it would be to stay smoke-free?&quot; Answered on a scale from 1 to 10 (1=really hard to stay quit, 10=really easy to stay quit).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="319"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline difficulty maintaining quit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="0.1449"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Explore difficulty maintaining quit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="0.1531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Build difficulty maintaining quit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="0.1891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>End of Mobilize difficulty maintaining quit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" spread="0.2055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mobile Smoking Cessation Program</title>
          <description>Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.&#xD;
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.</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="319"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="319"/>
              </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="319"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Senior Director of Clinical Affairs and Data Science</name_or_title>
      <organization>Pivot Health Technologies Inc.</organization>
      <phone>650-906-4255</phone>
      <email>craig@pivot.co</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/NCT03295643
org study id: C-601
nct id: NCT03295643
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Prospective, open label, single center clinical study enrolling 260 subjects in a mobile
      smoking cessation program using a smartphone app and a handheld breath sensor with coaching
      support over a six month period.
This is a prospective, open label, single center clinical study enrolling 260 subjects in a
      mobile smoking cessation program using a smartphone app and handheld breath sensor with
      coaching support over a six month period. Measurements include user engagement and retention
      in the program, attitude towards smoking and smoking behavior, quit rates, relapse rates, and
      quality of life over the study period, as well as user feedback on the program.

      Potential participants will complete an online screening form. Eligible participants will be
      called to confirm eligibility, discuss the study, and have their questions about the study
      answered. Interested eligible participants will then be emailed the registration link, which
      includes the electronic informed consent. After providing electronic informed consent,
      subjects register online and receive the hand held device which measures carbon monoxide (CO)
      which correlates to smoking behavior.

      Baseline questionnaires (demographics, smoking history, and attitude towards smoking) are
      completed, and subjects then self-train to use the breath sensor and smartphone app and
      allows viewing of CO sample values. The app also provides the user with ability to log
      cigarettes, view cigarette consumption trends, view instructional videos, complete
      educational activities and challenges, and engage with a coach.

      Participants will experience the program in 5 phases and then complete the study at
      approximately six months after enrolling,activating device and app.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All subjects experience same program
primary purpose: Other
masking: None (Open Label)
measure: Number of Participants Who Completed the Explore Stage
time frame: Assessment at the end of the Explore stage; 9 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
description: For the number of participants who started the Explore Stage, the proportion who completed the Explore Stage.
measure: Number of Participants Who Completed the Build Stage
time frame: Assessment at the end of the Build stage; between 10 and 37 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
description: For the number of participants who started the Build Stage, the proportion who completed the Build Stage.
measure: Number of Participants Who Completed the Mobilize Stage
time frame: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
description: For the number of participants who started the Mobilize Stage, the proportion who completed the Mobilize Stage.
measure: Number of Participants Who Completed the Quit Stage
time frame: Assessment at the end of the Quit Stage; between 24 and 51 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days.
description: For the number of participants who started the Quit Stage, the proportion who completed the Quit Stage.
measure: Number of Participants Who Completed the Secure Stage
time frame: Assessment at the end of the Secure Stage; between 101 and 128 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days. Quit = 7 days. Secure = 11 weeks.
description: For the number of participants who started the Secure Stage, the proportion who completed the Secure Stage.
measure: Readiness to Quit and Goals Related to Smoking Behavior
time frame: Assessment at the end of the Explore stage; 9 days after activating app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
description: Are you seriously thinking of quitting smoking? (stage of change) "Yes, within the next 30 days". "Yes, within the next 6 months". "No, not thinking of quitting".
measure: Average Percentage Change in Cigarettes Per Day (CPD) by the Pre-Quit Stage
time frame: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
description: Average percentage change in cigarettes per day (CPD) by the Pre-Quit Stage using repeated measures linear mixed model analysis.
Model uses all available data on CPD to estimate an average. The Pre-Quit Stage is defined as from the start of the study (activation of the app and device/ Baseline) to the end of the Mobilize Stage.
measure: Weeks of Active Engagement
time frame: 6 months
description: Engagement defined as interaction with the program at least once within app (app open, daily check-in, responds to coach, logs cigarettes, etc)
Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
Mobile smoking cessation program and CO breath sensor device: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
measure: Number of Participants Who Completed the Program
time frame: 6 months
description: The number of participants who completed the quit-smoking program.
measure: Quit Attempts
time frame: 6 months
description: Number attempt to quit by participant
measure: Quit Rate 7-day Point Prevalence
time frame: 6 months
description: Number of participant who have not smoked in last 7 days
measure: Quit Rate 30-day Point Prevalence
time frame: 6 months
description: Number of participant who have not smoked in last 30 days
measure: Number of Participants Who Reported Pivot Increased Their Motivation to Stop Smoking
time frame: 6 months
description: the number of participants who reported Pivot program (app, breath sensor, and coaching) increased their motivation to stop smoking
measure: Confidence to Quit
time frame: Assessment at the end of the Mobilize Stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
description: Confidence to quit. Estimate of means and standard errors based on linear mixed model.
Participants were asked: "If you were to quit smoking right now, how successful would you be?" Answered on a scale from 1 to 10 (1=not at all successful, 10=completely successful).
measure: Difficulty Maintaining Quit
time frame: Assessment at the end of the Mobilize stage; between 17 and 44 days after activating the app and device. Explore = 9 days. Build = 1 day to 4 weeks. Mobilize = 7 days.
description: Difficulty maintaining quit. Estimate of means and standard errors based on linear mixed model.
Participants were asked: "If you were to quit smoking right now, how difficult do you think it would be to stay smoke-free?" Answered on a scale from 1 to 10 (1=really hard to stay quit, 10=really easy to stay quit).
arm group label: Mobile smoking cessation program
arm group type: Other
description: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
intervention type: Device
intervention name: Mobile smoking cessation program and CO breath sensor device
description: Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
arm group label: Mobile smoking cessation program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Utley
role: Principal Investigator
affiliation: Pivot Health Technologies Inc.
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Pivot Health Technologies Inc.
investigator full name: Jennifer Marler, MD
investigator title: Senior Director, Clinical and Medical Affairs
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 