<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/NCT04409496</url>
  </required_header>
  <id_info>
    <org_study_id>UW 20-356</org_study_id>
    <nct_id>NCT04409496</nct_id>
  </id_info>
  <brief_title>Chat-based Support for Preventing Smoking Relapse</brief_title>
  <official_title>Chat-based Instant Messaging Support for Preventing Smoking Relapse in the Context of COVID-19 Outbreak: a Pilot Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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 pilot trial aims to evaluate the effectiveness of chat-based instant messaging support&#xD;
      in preventing smoking relapse in recent tobacco abstainers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking cessation is one of the most cost-effective health interventions, which can add up to&#xD;
      10 years of life expectancy (Jha et al., 2013). However, it is very difficult to quit smoking&#xD;
      because of the addictive effect of nicotine presents in tobacco products, and smokers&#xD;
      typically make multiple attempts before successfully quit smoking. Providing evidence-based&#xD;
      treatment could substantially increase the chance of successful quitting.&#xD;
&#xD;
      The Coronavirus Disease 2019 (COVID-19) provided new opportunities and challenges in&#xD;
      promoting smoking cessation. A growing literature has shown that smoking is linked to poor&#xD;
      progression of COVID-19 (Patanavanich &amp; Glantz, 2020), which can be a new warning for&#xD;
      motivating smokers to quit smoking. However, social distancing measures and increased stress&#xD;
      and anxiety related to fear of contracting COVID-19 may increase the risk of smoking relapse&#xD;
      in people who recently quit smoking (Patwardhan, 2020). There are also misinformation or&#xD;
      unproven claims that smoking can protect against COVID-19. The social distancing measures&#xD;
      also become a barrier for smokers who are interested in quitting to receive treatment from&#xD;
      smoking cessation clinics. Therefore, implementing new interventions that can address the&#xD;
      challenges in the context of the COVID-19 pandemic is needed.&#xD;
&#xD;
      Advance in mobile technologies provides a new avenue for delivering smoking cessation&#xD;
      support. A qualitative interview of 21 current smokers in Hong Kong has found that mobile&#xD;
      instant messaging app (e.g., WhatsApp) is an acceptable and feasible platform for providing&#xD;
      chat support for smoking cessation (Luk et al., 2019). Chat-based support allows a registered&#xD;
      nurse or trained counsellor to interact with a smoker individually through mobile instant&#xD;
      messaging apps (e.g., WhatsApp and WeChat) and provide real-time, continuous, and&#xD;
      personalized smoking cessation information and advice. A randomised trial of 1185 smokers&#xD;
      found that the chat-based intervention integrated with brief intervention was effective in&#xD;
      increasing smoking cessation (Wang et al., 2019). The trial also provided initial evidence&#xD;
      that the intervention can be delivered as a stand-alone treatment or in combination with use&#xD;
      of existing cessation treatment, to increase the chance of successful quitting. This study&#xD;
      aims to adapt the chat intervention for smoking relapse prevention and evaluate its&#xD;
      feasibility and effectiveness in recent tobacco abstainers enrolled in a clinic-based smoking&#xD;
      cessation service in Hong Kong.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Actual">January 22, 2021</completion_date>
  <primary_completion_date type="Actual">January 22, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemically-validated tobacco abstinence</measure>
    <time_frame>Assessed at 6 months after randomisation</time_frame>
    <description>Defined by an exhaled carbon monoxide level of 3 parts per million or below</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported 6-month prolonged tobacco abstinence</measure>
    <time_frame>Assessed at 6 months after randomisation</time_frame>
    <description>Not more than five lapses permitted for 6 months after baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported 7-day point-prevalence tobacco abstinence</measure>
    <time_frame>Assessed at 3 months after randomisation</time_frame>
    <description>Being completely smoke-free in the past 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported 7-day point-prevalence tobacco abstinence</measure>
    <time_frame>Assessed at 6 months after randomisation</time_frame>
    <description>Being completely smoke-free in the past 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported relapse rate</measure>
    <time_frame>Assessed at 3 months after randomisation</time_frame>
    <description>Defined as use of tobacco products for 7 consecutive days or longer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported relapse rate</measure>
    <time_frame>Assessed at 6 months after randomisation</time_frame>
    <description>Defined as use of tobacco products for 7 consecutive days or longer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in self-efficacy to quit smoking</measure>
    <time_frame>Assessed at 3 months after randomisation</time_frame>
    <description>Assessed by the Chinese version of the Smoking Self-efficacy Questionnaire (SEQ-12), which contains 12 Likert items ranging from 1 (not certain at all) to 5 (very certain) with higher scores indicating greater perceived confidence in resisting smoking.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-efficacy to quit smoking</measure>
    <time_frame>Assessed at 6 months after randomisation</time_frame>
    <description>Assessed by the Chinese version of the Smoking Self-efficacy Questionnaire (SEQ-12), which contains 12 Likert items ranging from 1 (not certain at all) to 5 (very certain) with higher scores indicating greater perceived confidence in resisting smoking.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nicotine withdrawal</measure>
    <time_frame>Assessed at 3 months after randomisation</time_frame>
    <description>Assessed by the Chinese verion of the Minnesota Nicotine Withdrawal Scale (MNWS), which contains 9 Likert items ranging from 0 (not at all) to 4 (very severe) with higher scores indicating greater nicotine withdrawal.</description>
  </other_outcome>
  <other_outcome>
    <measure>Nicotine withdrawal</measure>
    <time_frame>Assessed at 6 months after randomisation</time_frame>
    <description>Assessed by the Chinese verion of the Minnesota Nicotine Withdrawal Scale (MNWS), which contains 9 Likert items ranging from 0 (not at all) to 4 (very severe) with higher scores indicating greater nicotine withdrawal.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chat-based instant messaging support + Self-help booklet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SMS message support + Self-help booklet</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Chat-based instant messaging support</intervention_name>
    <description>Subjects will receive personalised instant messaging support for 12 weeks after baseline, address the five problems that contributed to smoking relapse:&#xD;
(1) lack of support for cessation, (2) negative mood or depression, (3) strong or prolonged withdrawal symptoms, (4) weight gain, and (5) smoking lapses. Updated information about the negative effect of smoking on risk of COVID-19 infection and prognosis will also be delivered.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS message support</intervention_name>
    <description>Subjects will receive regular SMS on generic smoking cessation for 3 months.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-help booklet</intervention_name>
    <description>Subjects will receive a standard self-help booklet on smoking relapse prevention.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong residents aged 18 years or older&#xD;
&#xD;
          -  Enrolled in a smoking cessation programme under Tung Wah Group of Hospitals Integrated&#xD;
             Centre on Smoking Cessation&#xD;
&#xD;
          -  Daily tobacco use before service intake&#xD;
&#xD;
          -  Not using any tobacco product for 3 to 30 days&#xD;
&#xD;
          -  Own a mobile phone with a mobile instant messaging app (WhatsApp or WeChat) installed&#xD;
&#xD;
          -  Able to communicate in Chinese (Cantonese or Mandarin)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with communication barriers owing to physical or cognitive conditions will be&#xD;
             excluded.&#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>Tzu Tsun Luk, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <reference>
    <citation>Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.</citation>
    <PMID>23343063</PMID>
  </reference>
  <reference>
    <citation>Patanavanich R, Glantz SA. Smoking Is Associated With COVID-19 Progression: A Meta-analysis. Nicotine Tob Res. 2020 Aug 24;22(9):1653-1656. doi: 10.1093/ntr/ntaa082.</citation>
    <PMID>32399563</PMID>
  </reference>
  <reference>
    <citation>Patwardhan P. COVID-19: Risk of increase in smoking rates among England's 6 million smokers and relapse among England's 11 million ex-smokers. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101067. doi: 10.3399/bjgpopen20X101067. Print 2020. No abstract available. Erratum In: BJGP Open. 2021 Feb 23;5(1):</citation>
    <PMID>32265183</PMID>
  </reference>
  <reference>
    <citation>Luk TT, Wong SW, Lee JJ, Chan SS, Lam TH, Wang MP. Exploring Community Smokers' Perspectives for Developing a Chat-Based Smoking Cessation Intervention Delivered Through Mobile Instant Messaging: Qualitative Study. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11954. doi: 10.2196/11954.</citation>
    <PMID>30702431</PMID>
  </reference>
  <reference>
    <citation>Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31.</citation>
    <PMID>33323188</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>March 2, 2021</last_update_submitted>
  <last_update_submitted_qc>March 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Tzu-Tsun Luk</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <keyword>Instant messaging</keyword>
  <keyword>Relapse prevention</keyword>
  <keyword>WhatsApp</keyword>
  <keyword>WeChat</keyword>
  <keyword>Chat intervention</keyword>
  <keyword>Chinese</keyword>
  <keyword>Mobile health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</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/NCT04409496
org study id: UW 20-356
nct id: NCT04409496
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot trial aims to evaluate the effectiveness of chat-based instant messaging support
      in preventing smoking relapse in recent tobacco abstainers.
Smoking cessation is one of the most cost-effective health interventions, which can add up to
      10 years of life expectancy (Jha et al., 2013). However, it is very difficult to quit smoking
      because of the addictive effect of nicotine presents in tobacco products, and smokers
      typically make multiple attempts before successfully quit smoking. Providing evidence-based
      treatment could substantially increase the chance of successful quitting.

      The Coronavirus Disease 2019 (COVID-19) provided new opportunities and challenges in
      promoting smoking cessation. A growing literature has shown that smoking is linked to poor
      progression of COVID-19 (Patanavanich & Glantz, 2020), which can be a new warning for
      motivating smokers to quit smoking. However, social distancing measures and increased stress
      and anxiety related to fear of contracting COVID-19 may increase the risk of smoking relapse
      in people who recently quit smoking (Patwardhan, 2020). There are also misinformation or
      unproven claims that smoking can protect against COVID-19. The social distancing measures
      also become a barrier for smokers who are interested in quitting to receive treatment from
      smoking cessation clinics. Therefore, implementing new interventions that can address the
      challenges in the context of the COVID-19 pandemic is needed.

      Advance in mobile technologies provides a new avenue for delivering smoking cessation
      support. A qualitative interview of 21 current smokers in Hong Kong has found that mobile
      instant messaging app (e.g., WhatsApp) is an acceptable and feasible platform for providing
      chat support for smoking cessation (Luk et al., 2019). Chat-based support allows a registered
      nurse or trained counsellor to interact with a smoker individually through mobile instant
      messaging apps (e.g., WhatsApp and WeChat) and provide real-time, continuous, and
      personalized smoking cessation information and advice. A randomised trial of 1185 smokers
      found that the chat-based intervention integrated with brief intervention was effective in
      increasing smoking cessation (Wang et al., 2019). The trial also provided initial evidence
      that the intervention can be delivered as a stand-alone treatment or in combination with use
      of existing cessation treatment, to increase the chance of successful quitting. This study
      aims to adapt the chat intervention for smoking relapse prevention and evaluate its
      feasibility and effectiveness in recent tobacco abstainers enrolled in a clinic-based smoking
      cessation service in Hong Kong.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Biochemically-validated tobacco abstinence
time frame: Assessed at 6 months after randomisation
description: Defined by an exhaled carbon monoxide level of 3 parts per million or below
measure: Self-reported 6-month prolonged tobacco abstinence
time frame: Assessed at 6 months after randomisation
description: Not more than five lapses permitted for 6 months after baseline
measure: Self-reported 7-day point-prevalence tobacco abstinence
time frame: Assessed at 3 months after randomisation
description: Being completely smoke-free in the past 7 days
measure: Self-reported 7-day point-prevalence tobacco abstinence
time frame: Assessed at 6 months after randomisation
description: Being completely smoke-free in the past 7 days
measure: Self-reported relapse rate
time frame: Assessed at 3 months after randomisation
description: Defined as use of tobacco products for 7 consecutive days or longer
measure: Self-reported relapse rate
time frame: Assessed at 6 months after randomisation
description: Defined as use of tobacco products for 7 consecutive days or longer
measure: Change in self-efficacy to quit smoking
time frame: Assessed at 3 months after randomisation
description: Assessed by the Chinese version of the Smoking Self-efficacy Questionnaire (SEQ-12), which contains 12 Likert items ranging from 1 (not certain at all) to 5 (very certain) with higher scores indicating greater perceived confidence in resisting smoking.
measure: Change in self-efficacy to quit smoking
time frame: Assessed at 6 months after randomisation
description: Assessed by the Chinese version of the Smoking Self-efficacy Questionnaire (SEQ-12), which contains 12 Likert items ranging from 1 (not certain at all) to 5 (very certain) with higher scores indicating greater perceived confidence in resisting smoking.
measure: Nicotine withdrawal
time frame: Assessed at 3 months after randomisation
description: Assessed by the Chinese verion of the Minnesota Nicotine Withdrawal Scale (MNWS), which contains 9 Likert items ranging from 0 (not at all) to 4 (very severe) with higher scores indicating greater nicotine withdrawal.
measure: Nicotine withdrawal
time frame: Assessed at 6 months after randomisation
description: Assessed by the Chinese verion of the Minnesota Nicotine Withdrawal Scale (MNWS), which contains 9 Likert items ranging from 0 (not at all) to 4 (very severe) with higher scores indicating greater nicotine withdrawal.
arm group label: Intervention group
arm group type: Experimental
description: Chat-based instant messaging support + Self-help booklet
arm group label: Control group
arm group type: Active Comparator
description: SMS message support + Self-help booklet
intervention type: Behavioral
intervention name: Chat-based instant messaging support
description: Subjects will receive personalised instant messaging support for 12 weeks after baseline, address the five problems that contributed to smoking relapse:
(1) lack of support for cessation, (2) negative mood or depression, (3) strong or prolonged withdrawal symptoms, (4) weight gain, and (5) smoking lapses. Updated information about the negative effect of smoking on risk of COVID-19 infection and prognosis will also be delivered.
arm group label: Intervention group
intervention type: Behavioral
intervention name: SMS message support
description: Subjects will receive regular SMS on generic smoking cessation for 3 months.
arm group label: Control group
intervention type: Behavioral
intervention name: Self-help booklet
description: Subjects will receive a standard self-help booklet on smoking relapse prevention.
arm group label: Control group
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tzu Tsun Luk, PhD, RN
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
citation: Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.
PMID: 23343063
citation: Patanavanich R, Glantz SA. Smoking Is Associated With COVID-19 Progression: A Meta-analysis. Nicotine Tob Res. 2020 Aug 24;22(9):1653-1656. doi: 10.1093/ntr/ntaa082.
PMID: 32399563
citation: Patwardhan P. COVID-19: Risk of increase in smoking rates among England's 6 million smokers and relapse among England's 11 million ex-smokers. BJGP Open. 2020 Jun 23;4(2):bjgpopen20X101067. doi: 10.3399/bjgpopen20X101067. Print 2020. No abstract available. Erratum In: BJGP Open. 2021 Feb 23;5(1):
PMID: 32265183
citation: Luk TT, Wong SW, Lee JJ, Chan SS, Lam TH, Wang MP. Exploring Community Smokers' Perspectives for Developing a Chat-Based Smoking Cessation Intervention Delivered Through Mobile Instant Messaging: Qualitative Study. JMIR Mhealth Uhealth. 2019 Jan 31;7(1):e11954. doi: 10.2196/11954.
PMID: 30702431
citation: Wang MP, Luk TT, Wu Y, Li WH, Cheung DY, Kwong AC, Lai V, Chan SS, Lam TH. Chat-based instant messaging support integrated with brief interventions for smoking cessation: a community-based, pragmatic, cluster-randomised controlled trial. Lancet Digit Health. 2019 Aug;1(4):e183-e192. doi: 10.1016/S2589-7500(19)30082-2. Epub 2019 Jul 31.
PMID: 33323188
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Tzu-Tsun Luk
investigator title: Research Assistant
mesh term: Recurrence
sharing ipd: No