<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/NCT03276767</url>
  </required_header>
  <id_info>
    <org_study_id>NFR 228158/H10-C</org_study_id>
    <nct_id>NCT03276767</nct_id>
  </id_info>
  <brief_title>Comparing SMS and E-mail Reminders in an Online Smoking Cessation Intervention</brief_title>
  <official_title>An RCT Comparing Reminders Sendt by SMS or by E-mail in an Online Smoking Cessation Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oslo</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>
      The primary purpose of the current study is to compare the effect of SMS-textmessage vs&#xD;
      e-mail reminders on user engagement and proportion of reported quit attempts in an online&#xD;
      smoking cessation intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Web- and mobile phone health behavior change interventions, including smoking cessation&#xD;
      programs, offer great promise, but little is known about how such interventions should be&#xD;
      designed to increase user engagement. The primary purpose of the current study is to compare&#xD;
      the effect of SMS-textmessage vs e-mail reminders on user engagement and proportion of&#xD;
      reported quit attempts in an online smoking cessation intervention.&#xD;
&#xD;
      The investigators propose a 2-arm RCT with 700 adult study participants that all receive a&#xD;
      best practices web-based smoking cessation program designed for use on smart phones&#xD;
      (web-app). The intervention includes a ten day preparation phase, in which participants&#xD;
      continue smoking. On the eleventh day (and onward) the user will receive a session in which&#xD;
      (s)he is asked whether (s)he has quit smoking or not. If not, the user will receive&#xD;
      additional treatment sessions until (s)he reports having quit (or dropped out of the study).&#xD;
      Each day (for up to 14 days) a new unique session is assigned to the user. However, if the&#xD;
      user does not log on to the web-intervention and starts using the session by noon on the&#xD;
      second day after assignment, the user will receive a reminder to do so. When a user is to be&#xD;
      sent a reminder for the first time, (s)he will be randomized to either receive such reminders&#xD;
      by SMS or by e-mail.&#xD;
&#xD;
      The primary outcome is reporting a quit attempt or not. Secondary outcomes include number&#xD;
      web-sessions started and completed and time spent navigating sessions after the first&#xD;
      reminder is received.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2022</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>
    <intervention_model_description>Participants receive one out of two versions of a web-based smoking cessation program. The only difference between the two versions is the medium of the reminder: either SMS-textmessage or e-mail.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The recruitment procedure and the treatment is fully automated and delivered by web, e-mail and SMS-textmessages - i.e., the participant is not contacted by any care providers, investigators or assessors during recruitment or treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Quit attempt</measure>
    <time_frame>Within 6 weeks after starting the first session of the intervention</time_frame>
    <description>User report a quit attempt</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of sessions completed</measure>
    <time_frame>Within 6 weeks after starting the first session of the intervention</time_frame>
    <description>Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of sessions started after first reminder</measure>
    <time_frame>Within 6 weeks after starting the first session of the intervention</time_frame>
    <description>Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Nicotine Dependence Tobacco Product</condition>
  <arm_group>
    <arm_group_label>Online intervention with SMS reminder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reminders will be sendt by SMS-TEXTMESSAGE if users of &quot;Endre&quot; does not log on to an assigned online session by noon on the second day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Online intervention with e-mail reminder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Reminder will be sendt by E-MAIL if users of &quot;Endre&quot; does not log on to an assigned online session by noon on the second day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endre</intervention_name>
    <description>The online intervention, &quot;Endre&quot;, a digital smoking cessation counsellor that communicates with the user primarily through interactive web-sessions. Intervention content is tailored based on user input and individual usage pattern. Up to 14 unique sessions is assigned to the users during the study period, one each day. If a user does not start a session by noon on the second day a reminder will be sendt.</description>
    <arm_group_label>Online intervention with SMS reminder</arm_group_label>
    <arm_group_label>Online intervention with e-mail reminder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  current smoker&#xD;
&#xD;
          -  determined to or considering to quit smoking&#xD;
&#xD;
          -  provide valid e-mail address&#xD;
&#xD;
          -  provide valid norwegian cell phone number&#xD;
&#xD;
          -  complete a baseline questionnaire&#xD;
&#xD;
          -  start using the intervention (pushing the next page button one time or more on the&#xD;
             first session provided)&#xD;
&#xD;
          -  has not logged on to any of the online session within noon on the second day after&#xD;
             that particular session was made available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not starting the first treatment session&#xD;
&#xD;
          -  Taking every treatment session on time (no need for reminders, and thus not&#xD;
             randomized)&#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>Håvar Brendryen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Oslo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Håvar Brendryen, PhD</last_name>
    <phone>99521714</phone>
    <phone_ext>+47</phone_ext>
    <email>brendryen@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Addictology, 1st Faculty of Medicine, Charles University</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Roman Gabrhelík, PhD</last_name>
      <email>gabrhelik@adiktologie.cz</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Norwegian Centre for Addiction Research</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Håvar Brendryen, PhD</last_name>
      <phone>99521714</phone>
      <phone_ext>+47</phone_ext>
      <email>brendryen@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Norway</country>
  </location_countries>
  <link>
    <url>https://www.sv.uio.no/psi/english/people/aca/haavabre/index.html</url>
    <description>Web page of PI</description>
  </link>
  <reference>
    <citation>Holter MT, Johansen A, Brendryen H. How a Fully Automated eHealth Program Simulates Three Therapeutic Processes: A Case Study. J Med Internet Res. 2016 Jun 28;18(6):e176. doi: 10.2196/jmir.5415.</citation>
    <PMID>27354373</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 30, 2021</last_update_submitted>
  <last_update_submitted_qc>September 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Håvar Brendryen</investigator_full_name>
    <investigator_title>Senior Research Scientist</investigator_title>
  </responsible_party>
  <keyword>online intervention</keyword>
  <keyword>e-Health</keyword>
  <keyword>reminder</keyword>
  <keyword>SMS-textmessage</keyword>
  <keyword>e-mail</keyword>
  <keyword>mobile phone</keyword>
  <keyword>cell phone</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>
  <!-- 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/NCT03276767
org study id: NFR 228158/H10-C
nct id: NCT03276767
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of the current study is to compare the effect of SMS-textmessage vs
      e-mail reminders on user engagement and proportion of reported quit attempts in an online
      smoking cessation intervention.
Web- and mobile phone health behavior change interventions, including smoking cessation
      programs, offer great promise, but little is known about how such interventions should be
      designed to increase user engagement. The primary purpose of the current study is to compare
      the effect of SMS-textmessage vs e-mail reminders on user engagement and proportion of
      reported quit attempts in an online smoking cessation intervention.

      The investigators propose a 2-arm RCT with 700 adult study participants that all receive a
      best practices web-based smoking cessation program designed for use on smart phones
      (web-app). The intervention includes a ten day preparation phase, in which participants
      continue smoking. On the eleventh day (and onward) the user will receive a session in which
      (s)he is asked whether (s)he has quit smoking or not. If not, the user will receive
      additional treatment sessions until (s)he reports having quit (or dropped out of the study).
      Each day (for up to 14 days) a new unique session is assigned to the user. However, if the
      user does not log on to the web-intervention and starts using the session by noon on the
      second day after assignment, the user will receive a reminder to do so. When a user is to be
      sent a reminder for the first time, (s)he will be randomized to either receive such reminders
      by SMS or by e-mail.

      The primary outcome is reporting a quit attempt or not. Secondary outcomes include number
      web-sessions started and completed and time spent navigating sessions after the first
      reminder is received.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants receive one out of two versions of a web-based smoking cessation program. The only difference between the two versions is the medium of the reminder: either SMS-textmessage or e-mail.
primary purpose: Prevention
masking: None (Open Label)
masking description: The recruitment procedure and the treatment is fully automated and delivered by web, e-mail and SMS-textmessages - i.e., the participant is not contacted by any care providers, investigators or assessors during recruitment or treatment.
measure: Quit attempt
time frame: Within 6 weeks after starting the first session of the intervention
description: User report a quit attempt
measure: Number of sessions completed
time frame: Within 6 weeks after starting the first session of the intervention
description: Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)
measure: Number of sessions started after first reminder
time frame: Within 6 weeks after starting the first session of the intervention
description: Counted from after first reminder until reported quitting or study dropout (a unique session is made available each day)
arm group label: Online intervention with SMS reminder
arm group type: Experimental
description: Reminders will be sendt by SMS-TEXTMESSAGE if users of "Endre" does not log on to an assigned online session by noon on the second day.
arm group label: Online intervention with e-mail reminder
arm group type: Active Comparator
description: Reminder will be sendt by E-MAIL if users of "Endre" does not log on to an assigned online session by noon on the second day.
intervention type: Other
intervention name: Endre
description: The online intervention, "Endre", a digital smoking cessation counsellor that communicates with the user primarily through interactive web-sessions. Intervention content is tailored based on user input and individual usage pattern. Up to 14 unique sessions is assigned to the users during the study period, one each day. If a user does not start a session by noon on the second day a reminder will be sendt.
arm group label: Online intervention with SMS reminder
arm group label: Online intervention with e-mail reminder
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Håvar Brendryen, PhD
role: Principal Investigator
affiliation: University of Oslo
last name: Håvar Brendryen, PhD
phone: 99521714
phone ext: +47
email: brendryen@gmail.com
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Czechia
country: Norway
url: https://www.sv.uio.no/psi/english/people/aca/haavabre/index.html
description: Web page of PI
citation: Holter MT, Johansen A, Brendryen H. How a Fully Automated eHealth Program Simulates Three Therapeutic Processes: A Case Study. J Med Internet Res. 2016 Jun 28;18(6):e176. doi: 10.2196/jmir.5415.
PMID: 27354373
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Håvar Brendryen
investigator title: Senior Research Scientist
mesh term: Tobacco Use Disorder
sharing ipd: No