<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/NCT03237949</url>
  </required_header>
  <id_info>
    <org_study_id>1.939.046</org_study_id>
    <nct_id>NCT03237949</nct_id>
  </id_info>
  <brief_title>Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts</brief_title>
  <official_title>Comparative Effectiveness of Text Messaging and Telephone Counseling for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Juiz de Fora</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Juiz de Fora</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>
      This is an extension of a previous feasibility study (Clinical Trials Registry -&#xD;
      NCT02571244). The actual study is a research aimed to compare the effectiveness of telephone&#xD;
      counseling and personalized text messages (TM) for supporting post-discharge quit attempts&#xD;
      among hospitalized smokers, with focus on smoking cessation as the main outcome. Smokers&#xD;
      patients will receive brief interventions and nicotine replacement therapy during the&#xD;
      hospitalization. After discharge smoker patients will be allocated into a intervention or&#xD;
      control arm. In the first and third months, after randomization, the patients will be contact&#xD;
      to smoke abstinence assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an extension of a previous feasibility study (Clinical Trials Registry -&#xD;
      NCT02571244). Background: Research suggests that smokers who receive treatment inside the&#xD;
      hospital and post-discharge follow up for at least a month is most likely to quit smoking&#xD;
      than those who didn't receive any intervention. The current challenge is to know the best way&#xD;
      to support post-discharge quit attempts in the Brazilian context. Objective: The aim of this&#xD;
      study is compare the effectiveness of personalized text messages (TM) and telephone&#xD;
      counseling to support smoking cessation between post discharge patients. Methods: All&#xD;
      patients admitted to the University Hospital of Juiz de Fora (HU/UFJF), between 06/2017 to&#xD;
      11/2018, will be asked about the cigarettes consumption in the last 30 days. Smokers patients&#xD;
      will receive brief interventions and nicotine replacement therapy during hospitalization.&#xD;
      After discharge these patients will be allocated into an intervention or control arm. The&#xD;
      intervention group will receive mobile phone TM twice a day up to fifteen days. The control&#xD;
      group will receive usual care (four telephone counseling sessions using motivational&#xD;
      interviewing approach). Results: At the first and third months, after randomization, the&#xD;
      patients will be contacted for smoke abstinence assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 30, 2017</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self Reported Smoking Abstinence</measure>
    <time_frame>Smoking abstinence at the first month after randomization</time_frame>
    <description>No smoking (even a puff) in the past 7 days at the first month follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self Reported Smoking Abstinence</measure>
    <time_frame>Smoking abstinence at the third month after randomization</time_frame>
    <description>No smoking (even a puff) in the past 7 days at the third month after randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbon monoxide verified Smoking Abstinence</measure>
    <time_frame>At third-month follow up</time_frame>
    <description>Carbon monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon monoxide ≤ 6.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction of Daily Cigarettes Consumption From Baseline</measure>
    <time_frame>At the third month after randomization</time_frame>
    <description>The self reported daily cigarettes consumption at the third month after randomization will be compared to the baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Tobacco Use Cessation</condition>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>Phone counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patient will receive standard care inside the hospital. After discharge the active comparator group will receive four phone counseling sessions. The sessions will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping skills with the goal of helping the participant build and implement a quit plan. The counseling timing, duration, and content will be consistent with guideline-based recommendations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Text message</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will receive standard care inside the hospital. After discharge the experimental group will receive extended care including text messages. Participants in this arm will be offered up to 30 text messages to help implement the quit plan discussed during the hospitalization. Patients motivated to quit in the next 30 days or that had already quit will receive 30 messages and patients unwilling to quit will receive 16 messages. The messages content follows the self efficacy theory.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Phone counseling</intervention_name>
    <description>Four telephone counseling sessions using a motivational interviewing approach</description>
    <arm_group_label>Phone counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Text message</intervention_name>
    <description>30 messages (2 per day) and patients unwilling to quit 16 (2 per day). The messages follows the self efficacy theory. The messages follows the self efficacy theory.</description>
    <arm_group_label>Text message</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Smoked cigarettes in the last 30 days (even a puff)&#xD;
&#xD;
          -  Have own mobile phone&#xD;
&#xD;
          -  Have received at least one text message in the last year&#xD;
&#xD;
          -  Have no problem with the mobile phone signal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Don't have a mobile phone&#xD;
&#xD;
          -  Unstable cognitive or physical condition&#xD;
&#xD;
          -  Physical or breath contact restrictions&#xD;
&#xD;
          -  Intensive care units&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Federal Hospital of Juiz de Fora</name>
      <address>
        <city>Juiz de Fora</city>
        <state>Minas Gerais</state>
        <zip>36038-330</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tobacco Use Disorder</keyword>
  <keyword>Hospitalized patients</keyword>
  <keyword>Text message</keyword>
  <keyword>Motivational Interview</keyword>
  <keyword>Substance-Related Disorders</keyword>
  <keyword>Behaviors and Mental Disorders</keyword>
  <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>
  <study_docs>
    <study_doc>
      <doc_id>NCT02571244</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://clinicaltrials.gov</doc_url>
      <doc_comment>This protocol is an extension of a previous research:Telephone Counseling and Text Messaging for Supporting Post-discharge Quit Attempts Among Hospitalized Smokers in Brazil, a feasibility study.</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03237949
org study id: 1.939.046
nct id: NCT03237949
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an extension of a previous feasibility study (Clinical Trials Registry -
      NCT02571244). The actual study is a research aimed to compare the effectiveness of telephone
      counseling and personalized text messages (TM) for supporting post-discharge quit attempts
      among hospitalized smokers, with focus on smoking cessation as the main outcome. Smokers
      patients will receive brief interventions and nicotine replacement therapy during the
      hospitalization. After discharge smoker patients will be allocated into a intervention or
      control arm. In the first and third months, after randomization, the patients will be contact
      to smoke abstinence assessment.
This is an extension of a previous feasibility study (Clinical Trials Registry -
      NCT02571244). Background: Research suggests that smokers who receive treatment inside the
      hospital and post-discharge follow up for at least a month is most likely to quit smoking
      than those who didn't receive any intervention. The current challenge is to know the best way
      to support post-discharge quit attempts in the Brazilian context. Objective: The aim of this
      study is compare the effectiveness of personalized text messages (TM) and telephone
      counseling to support smoking cessation between post discharge patients. Methods: All
      patients admitted to the University Hospital of Juiz de Fora (HU/UFJF), between 06/2017 to
      11/2018, will be asked about the cigarettes consumption in the last 30 days. Smokers patients
      will receive brief interventions and nicotine replacement therapy during hospitalization.
      After discharge these patients will be allocated into an intervention or control arm. The
      intervention group will receive mobile phone TM twice a day up to fifteen days. The control
      group will receive usual care (four telephone counseling sessions using motivational
      interviewing approach). Results: At the first and third months, after randomization, the
      patients will be contacted for smoke abstinence assessment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Self Reported Smoking Abstinence
time frame: Smoking abstinence at the first month after randomization
description: No smoking (even a puff) in the past 7 days at the first month follow up.
measure: Self Reported Smoking Abstinence
time frame: Smoking abstinence at the third month after randomization
description: No smoking (even a puff) in the past 7 days at the third month after randomization.
measure: Carbon monoxide verified Smoking Abstinence
time frame: At third-month follow up
description: Carbon monoxide verified Smoking Abstinence at third-month follow up. Abstinence defined as Carbon monoxide ≤ 6.
measure: Reduction of Daily Cigarettes Consumption From Baseline
time frame: At the third month after randomization
description: The self reported daily cigarettes consumption at the third month after randomization will be compared to the baseline.
arm group label: Phone counseling
arm group type: Active Comparator
description: The patient will receive standard care inside the hospital. After discharge the active comparator group will receive four phone counseling sessions. The sessions will provide basic information about smoking and successful quitting. The counselor will use motivational interview techniques to build coping skills with the goal of helping the participant build and implement a quit plan. The counseling timing, duration, and content will be consistent with guideline-based recommendations.
arm group label: Text message
arm group type: Experimental
description: The patient will receive standard care inside the hospital. After discharge the experimental group will receive extended care including text messages. Participants in this arm will be offered up to 30 text messages to help implement the quit plan discussed during the hospitalization. Patients motivated to quit in the next 30 days or that had already quit will receive 30 messages and patients unwilling to quit will receive 16 messages. The messages content follows the self efficacy theory.
intervention type: Behavioral
intervention name: Phone counseling
description: Four telephone counseling sessions using a motivational interviewing approach
arm group label: Phone counseling
intervention type: Behavioral
intervention name: Text message
description: 30 messages (2 per day) and patients unwilling to quit 16 (2 per day). The messages follows the self efficacy theory. The messages follows the self efficacy theory.
arm group label: Text message
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
sharing ipd: No
study doc: 