<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/NCT03800719</url>
  </required_header>
  <id_info>
    <org_study_id>Personalized IM+referral</org_study_id>
    <nct_id>NCT03800719</nct_id>
  </id_info>
  <brief_title>Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation</brief_title>
  <official_title>Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation in Smokers Proactively Recruited From Smoking Hotspots in Hong Kong: a Pragmatic Randomized Controlled 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 study aims to assess the effect of personalized support using instant messaging&#xD;
      application on smoking cessation in smokers proactively recruited from smoking hotspots in&#xD;
      Hong Kong.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed Description: With the advancement of information communication technologies (ICTs),&#xD;
      instant messaging applications (IM Apps, e.g. WhatsApp and WeChat) can be used for providing&#xD;
      synchronous, personalized, interactive interventions for health promotion. This study&#xD;
      proposes to apply IM Apps for enhancing our tested brief smoking cessation (SC) intervention&#xD;
      model from AWARD to e-AWARD (AWARD: Ask, Warn, Advise, Refer, Do-it-again,) without&#xD;
      medications to increase SC in smokers proactively recruited in smoking hotspots in Hong Kong.&#xD;
      Such smokers are the majority and have low quit rate. IM Apps allows trained SC advisors to&#xD;
      proactively deliver personalized SC advices, response to smokers' needs promptly, and provide&#xD;
      psychosocial support. No similar trials are found in PubMed, Cochrane Library and trial&#xD;
      registries (ClinicalTrials.gov &amp; ISRCTN) (except the pilot trial of this study). The aims of&#xD;
      this study are as follows:&#xD;
&#xD;
        1. To assess the main effect of the personalized support using instant messaging&#xD;
           applications (Intervention) vs. Control group on biochemical validated smoking&#xD;
           abstinence at 6-month and 12-month.&#xD;
&#xD;
        2. To assess the effects on self-reported past 7-day abstinence, 24-week continuous&#xD;
           abstinence, smoking reduction, self-efficacy of quitting, intention to quit, quit&#xD;
           attempts and SC medications and services use at 6-month and 12-month.&#xD;
&#xD;
        3. To identify the mediators, which can inform mechanisms of the intervention on SC.&#xD;
&#xD;
        4. To evaluate the cost-effectiveness of the above interventions.&#xD;
&#xD;
        5. To understand the effects subjects' experience of IM support on SC using a qualitative&#xD;
           study approach.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemically-validated abstinence at 6-month</measure>
    <time_frame>6-month after baseline</time_frame>
    <description>Defined as exhaled carbon monoxide &lt;4ppm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biochemically-validated abstinence at 12-month</measure>
    <time_frame>12-month after baseline</time_frame>
    <description>Defined as exhaled carbon monoxide &lt;4ppm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported past 7-day abstinence</measure>
    <time_frame>6-month and 12-month after baseline</time_frame>
    <description>Self-reported no cigarette smoking (even a single puff) in the past 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported 24-week continuous abstinence</measure>
    <time_frame>6-month and 12-month after baseline</time_frame>
    <description>Self-reported no cigarette smoking (even a single puff) in the past 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking reduction</measure>
    <time_frame>6-month and 12-month after baseline</time_frame>
    <description>Self-reported reduction in the number of cigarettes smoked daily by at least 50% of the baseline amount</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived importance, confidence and difficulties of quitting</measure>
    <time_frame>6-month and 12-month after baseline</time_frame>
    <description>Perceived importance, confidence and difficulties of quitting measured on a scale of 0-10 and a higher score indicates a stronger perception</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intention to quit</measure>
    <time_frame>6-month and 12-month after baseline</time_frame>
    <description>Any intention to quit smoking (yes/no) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quit attempts</measure>
    <time_frame>6-month and 12-month after baseline</time_frame>
    <description>Number of quit attempts from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smoking cessation medication use</measure>
    <time_frame>6-month and 12-month after baseline</time_frame>
    <description>Any use of nicotine replacement therapy from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Smocking cessation services use</measure>
    <time_frame>6-month and 12-month after baseline</time_frame>
    <description>Any use of counselling, hotline, SC clinics and other SC services from baseline</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">696</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, regular messages through Instant Messaging (IM), psychosocial support and referral to SC services through IM</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, SMS message on general health</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>AWARD advice</intervention_name>
    <description>At baseline, brief smoking cessation advice following AWARD model will be delivered to subjects within about 2 to 5 minutes:&#xD;
Ask about smoking history and habit&#xD;
Warn about the risks of smoking using a leaflet&#xD;
Advise to quit smoking as soon as possible and use nicotine replacement therapy (NRT) or SC services&#xD;
Refer subjects to free smoking cessation services in Hong Kong if they agree&#xD;
Do it again: smokers who have tried to quit but relapsed will be encouraged to quit again and those who have reduced smoking will be advised to further reduce or quit smoking</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health warning leaflet</intervention_name>
    <description>At baseline, an A5-sized leaflet will be given to subjects, which includes information about risks of smoking, pictures of smoking-related diseases, and smoking cessation services provided in Hong Kong.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active referral to smoking cessation (SC) services</intervention_name>
    <description>At baseline, subjects will be encouraged to seek smoking cessation services in Hong Kong. If subjects agree, their contact information will be sent to the preferred service providers for a quick appointment and follow-up.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Regular messages through Instant Messaging (IM)</intervention_name>
    <description>A total of pre-set 26 messages will be sent to subjects through WhatsApp 12 weeks after baseline to remind the quit date and to encourage abstinence. Messages are tailored based on subjects' sociodemographic characteristics and smoking habit following Social Cognitive Theory and Transtheoretical Model. Messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. The schedule will be adjusted according to the quit date and also smokers' requests. The format of regular messages will mainly be text-based but also include pictures, animations and videos.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial support and referral to SC services through IM</intervention_name>
    <description>Personalized interactive text or voice conversation will be provided by trained smoking cessation advisors through WhatsApp for 3 months after baseline. Advisors will periodically proactively send messages to subjects to initiate the conversation (e.g. asking recent progress of smoking cessation) and deliver evidence-based advice. Advisors will also actively refer subjects, if they have expressed the need, to smoking cessation services providers. A standard operation algorithm for advisors used in the pilot feasibility trial will be modified for the use.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Message on general health delivered by short message service (SMS)</intervention_name>
    <description>After baseline, regular messages using SMS will be sent to subjects with similar frequency to Intervention group. The messages include information on general health and reminders on follow-up surveys and biochemical validation for quitting.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult smokers aged 18+ who smoke cigarette(s) daily.&#xD;
&#xD;
          -  Exhaled carbon monoxide (CO) level of 4ppm or above.&#xD;
&#xD;
          -  Having smartphones with IM Apps (WhatsApp) and have experience in using.&#xD;
&#xD;
          -  Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers who have psychiatric/psychological diseases or are on regular psychotropic&#xD;
             medications.&#xD;
&#xD;
          -  Smokers who are using SC medication, NRT, other SC services or projects.&#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_contact>
    <last_name>Fleur Lee, MPhil</last_name>
    <phone>+852-39176955</phone>
    <email>fleurlee@hku.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>School of Nursing, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <zip>000000</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fleur Lee, MPhil</last_name>
      <phone>+852-39176955</phone>
      <email>fleurlee@hku.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
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    <citation>Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77-101.</citation>
  </reference>
  <reference>
    <citation>Michie S, Hyder N, Walia A, West R. Development of a taxonomy of behaviour change techniques used in individual behavioural support for smoking cessation. Addict Behav. 2011 Apr;36(4):315-9. doi: 10.1016/j.addbeh.2010.11.016. Epub 2010 Dec 15.</citation>
    <PMID>21215528</PMID>
  </reference>
  <reference>
    <citation>A clinical practice guideline for treating tobacco use and dependence: A US Public Health Service report. The Tobacco Use and Dependence Clinical Practice Guideline Panel, Staff, and Consortium Representatives. JAMA. 2000 Jun 28;283(24):3244-54.</citation>
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  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>September 26, 2019</last_update_submitted>
  <last_update_submitted_qc>September 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</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>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>smoking cessation</keyword>
  <keyword>active referral</keyword>
  <keyword>IM</keyword>
  <!-- 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/NCT03800719
org study id: Personalized IM+referral
nct id: NCT03800719
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the effect of personalized support using instant messaging
      application on smoking cessation in smokers proactively recruited from smoking hotspots in
      Hong Kong.
Detailed Description: With the advancement of information communication technologies (ICTs),
      instant messaging applications (IM Apps, e.g. WhatsApp and WeChat) can be used for providing
      synchronous, personalized, interactive interventions for health promotion. This study
      proposes to apply IM Apps for enhancing our tested brief smoking cessation (SC) intervention
      model from AWARD to e-AWARD (AWARD: Ask, Warn, Advise, Refer, Do-it-again,) without
      medications to increase SC in smokers proactively recruited in smoking hotspots in Hong Kong.
      Such smokers are the majority and have low quit rate. IM Apps allows trained SC advisors to
      proactively deliver personalized SC advices, response to smokers' needs promptly, and provide
      psychosocial support. No similar trials are found in PubMed, Cochrane Library and trial
      registries (ClinicalTrials.gov & ISRCTN) (except the pilot trial of this study). The aims of
      this study are as follows:

        1. To assess the main effect of the personalized support using instant messaging
           applications (Intervention) vs. Control group on biochemical validated smoking
           abstinence at 6-month and 12-month.

        2. To assess the effects on self-reported past 7-day abstinence, 24-week continuous
           abstinence, smoking reduction, self-efficacy of quitting, intention to quit, quit
           attempts and SC medications and services use at 6-month and 12-month.

        3. To identify the mediators, which can inform mechanisms of the intervention on SC.

        4. To evaluate the cost-effectiveness of the above interventions.

        5. To understand the effects subjects' experience of IM support on SC using a qualitative
           study approach.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Biochemically-validated abstinence at 6-month
time frame: 6-month after baseline
description: Defined as exhaled carbon monoxide <4ppm
measure: Biochemically-validated abstinence at 12-month
time frame: 12-month after baseline
description: Defined as exhaled carbon monoxide <4ppm
measure: Self-reported past 7-day abstinence
time frame: 6-month and 12-month after baseline
description: Self-reported no cigarette smoking (even a single puff) in the past 7 days
measure: Self-reported 24-week continuous abstinence
time frame: 6-month and 12-month after baseline
description: Self-reported no cigarette smoking (even a single puff) in the past 24 weeks
measure: Smoking reduction
time frame: 6-month and 12-month after baseline
description: Self-reported reduction in the number of cigarettes smoked daily by at least 50% of the baseline amount
measure: Perceived importance, confidence and difficulties of quitting
time frame: 6-month and 12-month after baseline
description: Perceived importance, confidence and difficulties of quitting measured on a scale of 0-10 and a higher score indicates a stronger perception
measure: Intention to quit
time frame: 6-month and 12-month after baseline
description: Any intention to quit smoking (yes/no) from baseline
measure: Quit attempts
time frame: 6-month and 12-month after baseline
description: Number of quit attempts from baseline
measure: Smoking cessation medication use
time frame: 6-month and 12-month after baseline
description: Any use of nicotine replacement therapy from baseline
measure: Smocking cessation services use
time frame: 6-month and 12-month after baseline
description: Any use of counselling, hotline, SC clinics and other SC services from baseline
arm group label: Intervention Group
arm group type: Experimental
description: AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, regular messages through Instant Messaging (IM), psychosocial support and referral to SC services through IM
arm group label: Control Group
arm group type: Active Comparator
description: AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, SMS message on general health
intervention type: Behavioral
intervention name: AWARD advice
description: At baseline, brief smoking cessation advice following AWARD model will be delivered to subjects within about 2 to 5 minutes:
Ask about smoking history and habit
Warn about the risks of smoking using a leaflet
Advise to quit smoking as soon as possible and use nicotine replacement therapy (NRT) or SC services
Refer subjects to free smoking cessation services in Hong Kong if they agree
Do it again: smokers who have tried to quit but relapsed will be encouraged to quit again and those who have reduced smoking will be advised to further reduce or quit smoking
arm group label: Control Group
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Health warning leaflet
description: At baseline, an A5-sized leaflet will be given to subjects, which includes information about risks of smoking, pictures of smoking-related diseases, and smoking cessation services provided in Hong Kong.
arm group label: Control Group
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Active referral to smoking cessation (SC) services
description: At baseline, subjects will be encouraged to seek smoking cessation services in Hong Kong. If subjects agree, their contact information will be sent to the preferred service providers for a quick appointment and follow-up.
arm group label: Control Group
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Regular messages through Instant Messaging (IM)
description: A total of pre-set 26 messages will be sent to subjects through WhatsApp 12 weeks after baseline to remind the quit date and to encourage abstinence. Messages are tailored based on subjects' sociodemographic characteristics and smoking habit following Social Cognitive Theory and Transtheoretical Model. Messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. The schedule will be adjusted according to the quit date and also smokers' requests. The format of regular messages will mainly be text-based but also include pictures, animations and videos.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Psychosocial support and referral to SC services through IM
description: Personalized interactive text or voice conversation will be provided by trained smoking cessation advisors through WhatsApp for 3 months after baseline. Advisors will periodically proactively send messages to subjects to initiate the conversation (e.g. asking recent progress of smoking cessation) and deliver evidence-based advice. Advisors will also actively refer subjects, if they have expressed the need, to smoking cessation services providers. A standard operation algorithm for advisors used in the pilot feasibility trial will be modified for the use.
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Message on general health delivered by short message service (SMS)
description: After baseline, regular messages using SMS will be sent to subjects with similar frequency to Intervention group. The messages include information on general health and reminders on follow-up surveys and biochemical validation for quitting.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fleur Lee, MPhil
phone: +852-39176955
email: fleurlee@hku.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
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responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Wang Man-Ping
investigator title: Assistant Professor