<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/NCT04399967</url>
  </required_header>
  <id_info>
    <org_study_id>QTW 2020</org_study_id>
    <nct_id>NCT04399967</nct_id>
  </id_info>
  <brief_title>COVID-19 Brief Advice and Chat-based Support for Smoking Cessation Via &quot;Quit to Win&quot; Contest 2020</brief_title>
  <acronym>QTW2020</acronym>
  <official_title>Building Capacity and Promoting Smoking Cessation in the Community Via &quot;Quit to Win&quot; Contest 2020: a Single-blind Randomized Controlled Trial on COVID-19 Related Brief Advice and Personalized Chat-based Intervention for Smoking Cessation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hong Kong Council on Smoking and Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>Yes</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 present study will examine (1) the effectiveness of a combined brief advice and&#xD;
      personalized chat-based support on COVID-19 related smoking messages and (2) explore the use&#xD;
      of CBPR model to build capacity and to engage community partners in taking on this important&#xD;
      public health issue for sustainability in the community. In addition, a process evaluation&#xD;
      will be conducted to assess the effectiveness of the recruitment activity and how it is&#xD;
      linked with the overall program outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking is detrimental to the immune system and can cause respiratory tract infection.&#xD;
      Growing evidence has suggested that compared to non-smokers, COVID-19 patients who have a&#xD;
      history of smoking are at a higher risk of developing severe respiratory and cardiovascular&#xD;
      symptoms, consequently may require mechanical ventilation and intensive care. A case series&#xD;
      of 1,099 COVID-19 patients in China has found that ever smokers, compared with never smokers,&#xD;
      were more likely to have severe COVID-19 disease upon hospital admission and be admitted to&#xD;
      intensive care unit, need to use mechanical ventilation, and die. The result is corroborated&#xD;
      by a multivariable analysis of 78 COVID-19 pneumonia cases in China, which identified smoking&#xD;
      as the only preventable risk factor for disease progression. While the link between smoking&#xD;
      and the COVID-19 needs further research, smokers appear to be at a greater risk of suffering&#xD;
      from serious symptoms due to COVID-19.&#xD;
&#xD;
      The practice of smoking might also predispose smokers to COVID-19 infection. Smoking behavior&#xD;
      is characterized by inhalation and the hand-to-mouth movements which increase the possibility&#xD;
      of transmission of virus from contaminated fingers and cigarettes to mouth. In Hong Kong,&#xD;
      where smoking is banned in indoor public areas and workplace, smokers often gather and smoke&#xD;
      at smoking hotspots outdoor, where ashtrays are available. This increases their risk of&#xD;
      infection since the smokers are in close contact with each other and have to remove their&#xD;
      mask to smoke. Exhaling smoke also aids the spreading the virus in the air. However,&#xD;
      misleading information that smoking can prevent COVID-19 infection is widespread on social&#xD;
      media.&#xD;
&#xD;
      Public health strategies (e.g., social distancing, staying at home and working from home) may&#xD;
      motivate some smokers to reduce or to quit smoking due to the inconvenience to smoke indoor&#xD;
      and to buy cigarettes from retail outlets. However, home confinement may result in social&#xD;
      isolation and psychological distress (anxiety and stress) both increasing the need for&#xD;
      smoking. Some smokers who are not used to smoke at home might be prompted to smoke at home to&#xD;
      cope with their craving during lockdown or work from home, which may also expose their family&#xD;
      members from second-hand smoke.&#xD;
&#xD;
      Our RCT in QTW Contest 2017 evaluated the effectiveness of a chat-based intervention&#xD;
      delivered through a mobile instant messaging application (WhatsApp) plus active referral to&#xD;
      SC services to increase quitting. Chat-based intervention resulted in higher abstinence rate&#xD;
      compared with the control group at 6-month follow-up. In QTW Contest 2019, we evaluated the&#xD;
      effectiveness of a combined intervention of AWARD advice, active referral, instant messaging&#xD;
      and optional cocktail intervention to increase abstinence. The preliminary result showed that&#xD;
      the personalized instant messaging (PIM) group and regular instant messaging (RIM) group had&#xD;
      similar abstinence rate at 6-month follow-up.&#xD;
&#xD;
      Therefore, the present study will examine (1) the effectiveness of a combined brief advice&#xD;
      and personalized chat-based support on COVID-19 related smoking messages and (2) explore the&#xD;
      use of CBPR model to build capacity and to engage community partners in taking on this&#xD;
      important public health issue for sustainability in the community. In addition, a process&#xD;
      evaluation will be conducted to assess the effectiveness of the recruitment activity and how&#xD;
      it is linked with the overall program outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemical validated quit rate</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>The primary outcomes are biochemically validated quit rates (exhaled CO &lt; 4 ppm or salivary cotinine &lt; 30 ng/ml) at 3-month in the two groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biochemical validated quit rate</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>The primary outcomes are biochemically validated quit rates (exhaled CO &lt; 4 ppm or salivary cotinine &lt; 30 ng/ml) at 6-month in the two groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking quit rate change from baseline at 3-month follow-up</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>Self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking quit rate change from baseline at 6-month follow-up</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking reduction rate change from baseline at 3-month follow-up</measure>
    <time_frame>3-month follow-up</time_frame>
    <description>Rate of smoking reduction by at least half of baseline amount in the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking reduction rate change from baseline at 6-month follow-up</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Rate of smoking reduction by at least half of baseline amount in the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement in chat-based/text-based support</measure>
    <time_frame>3 and 6 months follow-up</time_frame>
    <description>Self-reported engagement in chat-based/SMS-based support in the two groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1166</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 support+ COVID-19 specific advice + AWARD advice + COVID-related health warning leaflet + referral card + COSH booklet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Text-based support + AWARD advice + warning leaflet + referral card + COSH booklet</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Chat-based support</intervention_name>
    <description>Participants will receive three months of chat-based support through IM apps (e.g. WhatsApp, WeChat). The regular messages and instant messaging on psychosocial support aim to provide hygienic advice to reduce the risk of exposure to SARS-cov2, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AWARD plus COVID-specific advice</intervention_name>
    <description>Ask about smoking history, Warn about the risks associated with the COVID-19 and smoking (with a COVID-related health warning leaflet), Advise to quit as soon as possible during the COVID-19 pandemic, Refer smokers to SC services (with a referral card, see below for information), and Do it again: to repeat the intervention</description>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Ask, Warn, Advise, Refer, Do-it-again</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AWARD advice</intervention_name>
    <description>Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Ask, Warn, Advise, Refer, Do-it-again</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COVID-19 related health warning leaflet</intervention_name>
    <description>The 2-sided color printed A4 leaflet, which covers the risk of COVID-19 and smoking and the most important messages to motivate smoking cessation</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health warning leaflet</intervention_name>
    <description>The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation.</description>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>Brief leaflet on health warning and smoking cessation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS-based support</intervention_name>
    <description>Participants will receive regular SMS with similar frequency to Intervention group but with generic information on smoking cessation.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Referral card</intervention_name>
    <description>The 3-folded &quot;Smoking Cessation Services&quot; card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
    <other_name>Smoking Cessation Service Card</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COSH Self-help smoking cessation booklet</intervention_name>
    <description>A general smoking cessation self-help booklet</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 or above&#xD;
&#xD;
          -  Smoke at least 1 tobacco stick per day or use e-cigarette daily in the past 3-month&#xD;
&#xD;
          -  Able to communicate in Cantonese (including reading Chinese)&#xD;
&#xD;
          -  Saliva cotinine 30 ng/ml or above&#xD;
&#xD;
          -  Intent to quit / reduce smoking&#xD;
&#xD;
          -  Able to use instant messaging tool (e.g., WhatsApp, WeChat) for communication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers who have communication barrier (either physically or cognitively)&#xD;
&#xD;
          -  Smokers who are currently participating in other SC programmes or services&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Man Ping Kelvin Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hong Kong Council on Smoking and Health (COSH)</name>
      <address>
        <city>Hong Kong</city>
        <state>Hong Kong</state>
        <zip>852</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</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>Dr. Wang Man-Ping</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Smoking cessation</keyword>
  <keyword>Quit to Win</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</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/NCT04399967
org study id: QTW 2020
nct id: NCT04399967
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study will examine (1) the effectiveness of a combined brief advice and
      personalized chat-based support on COVID-19 related smoking messages and (2) explore the use
      of CBPR model to build capacity and to engage community partners in taking on this important
      public health issue for sustainability in the community. In addition, a process evaluation
      will be conducted to assess the effectiveness of the recruitment activity and how it is
      linked with the overall program outcomes.
Smoking is detrimental to the immune system and can cause respiratory tract infection.
      Growing evidence has suggested that compared to non-smokers, COVID-19 patients who have a
      history of smoking are at a higher risk of developing severe respiratory and cardiovascular
      symptoms, consequently may require mechanical ventilation and intensive care. A case series
      of 1,099 COVID-19 patients in China has found that ever smokers, compared with never smokers,
      were more likely to have severe COVID-19 disease upon hospital admission and be admitted to
      intensive care unit, need to use mechanical ventilation, and die. The result is corroborated
      by a multivariable analysis of 78 COVID-19 pneumonia cases in China, which identified smoking
      as the only preventable risk factor for disease progression. While the link between smoking
      and the COVID-19 needs further research, smokers appear to be at a greater risk of suffering
      from serious symptoms due to COVID-19.

      The practice of smoking might also predispose smokers to COVID-19 infection. Smoking behavior
      is characterized by inhalation and the hand-to-mouth movements which increase the possibility
      of transmission of virus from contaminated fingers and cigarettes to mouth. In Hong Kong,
      where smoking is banned in indoor public areas and workplace, smokers often gather and smoke
      at smoking hotspots outdoor, where ashtrays are available. This increases their risk of
      infection since the smokers are in close contact with each other and have to remove their
      mask to smoke. Exhaling smoke also aids the spreading the virus in the air. However,
      misleading information that smoking can prevent COVID-19 infection is widespread on social
      media.

      Public health strategies (e.g., social distancing, staying at home and working from home) may
      motivate some smokers to reduce or to quit smoking due to the inconvenience to smoke indoor
      and to buy cigarettes from retail outlets. However, home confinement may result in social
      isolation and psychological distress (anxiety and stress) both increasing the need for
      smoking. Some smokers who are not used to smoke at home might be prompted to smoke at home to
      cope with their craving during lockdown or work from home, which may also expose their family
      members from second-hand smoke.

      Our RCT in QTW Contest 2017 evaluated the effectiveness of a chat-based intervention
      delivered through a mobile instant messaging application (WhatsApp) plus active referral to
      SC services to increase quitting. Chat-based intervention resulted in higher abstinence rate
      compared with the control group at 6-month follow-up. In QTW Contest 2019, we evaluated the
      effectiveness of a combined intervention of AWARD advice, active referral, instant messaging
      and optional cocktail intervention to increase abstinence. The preliminary result showed that
      the personalized instant messaging (PIM) group and regular instant messaging (RIM) group had
      similar abstinence rate at 6-month follow-up.

      Therefore, the present study will examine (1) the effectiveness of a combined brief advice
      and personalized chat-based support on COVID-19 related smoking messages and (2) explore the
      use of CBPR model to build capacity and to engage community partners in taking on this
      important public health issue for sustainability in the community. In addition, a process
      evaluation will be conducted to assess the effectiveness of the recruitment activity and how
      it is linked with the overall program outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Biochemical validated quit rate
time frame: 3-month follow-up
description: The primary outcomes are biochemically validated quit rates (exhaled CO < 4 ppm or salivary cotinine < 30 ng/ml) at 3-month in the two groups
measure: Biochemical validated quit rate
time frame: 6-month follow-up
description: The primary outcomes are biochemically validated quit rates (exhaled CO < 4 ppm or salivary cotinine < 30 ng/ml) at 6-month in the two groups
measure: Smoking quit rate change from baseline at 3-month follow-up
time frame: 3-month follow-up
description: Self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups
measure: Smoking quit rate change from baseline at 6-month follow-up
time frame: 6-month follow-up
description: Self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups
measure: Smoking reduction rate change from baseline at 3-month follow-up
time frame: 3-month follow-up
description: Rate of smoking reduction by at least half of baseline amount in the two groups
measure: Smoking reduction rate change from baseline at 6-month follow-up
time frame: 6-month follow-up
description: Rate of smoking reduction by at least half of baseline amount in the two groups
measure: Engagement in chat-based/text-based support
time frame: 3 and 6 months follow-up
description: Self-reported engagement in chat-based/SMS-based support in the two groups
arm group label: Intervention Group
arm group type: Experimental
description: Chat-based support+ COVID-19 specific advice + AWARD advice + COVID-related health warning leaflet + referral card + COSH booklet
arm group label: Control Group
arm group type: Experimental
description: Text-based support + AWARD advice + warning leaflet + referral card + COSH booklet
intervention type: Behavioral
intervention name: Chat-based support
description: Participants will receive three months of chat-based support through IM apps (e.g. WhatsApp, WeChat). The regular messages and instant messaging on psychosocial support aim to provide hygienic advice to reduce the risk of exposure to SARS-cov2, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: AWARD plus COVID-specific advice
description: Ask about smoking history, Warn about the risks associated with the COVID-19 and smoking (with a COVID-related health warning leaflet), Advise to quit as soon as possible during the COVID-19 pandemic, Refer smokers to SC services (with a referral card, see below for information), and Do it again: to repeat the intervention
arm group label: Intervention Group
other name: Ask, Warn, Advise, Refer, Do-it-again
intervention type: Behavioral
intervention name: AWARD advice
description: Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
arm group label: Control Group
other name: Ask, Warn, Advise, Refer, Do-it-again
intervention type: Behavioral
intervention name: COVID-19 related health warning leaflet
description: The 2-sided color printed A4 leaflet, which covers the risk of COVID-19 and smoking and the most important messages to motivate smoking cessation
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Health warning leaflet
description: The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation.
arm group label: Control Group
other name: Brief leaflet on health warning and smoking cessation
intervention type: Behavioral
intervention name: SMS-based support
description: Participants will receive regular SMS with similar frequency to Intervention group but with generic information on smoking cessation.
arm group label: Control Group
intervention type: Behavioral
intervention name: Referral card
description: The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans.
arm group label: Control Group
arm group label: Intervention Group
other name: Smoking Cessation Service Card
intervention type: Behavioral
intervention name: COSH Self-help smoking cessation booklet
description: A general smoking cessation self-help booklet
arm group label: Control Group
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Man Ping Kelvin Wang, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Wang Man-Ping
investigator title: Associate Professor
mesh term: COVID-19
sharing ipd: No