- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409496
Chat-based Support for Preventing Smoking Relapse
Chat-based Instant Messaging Support for Preventing Smoking Relapse in the Context of COVID-19 Outbreak: a Pilot Randomised Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong
- Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hong Kong residents aged 18 years or older
- Enrolled in a smoking cessation programme under Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
- Daily tobacco use before service intake
- Not using any tobacco product for 3 to 30 days
- Own a mobile phone with a mobile instant messaging app (WhatsApp or WeChat) installed
- Able to communicate in Chinese (Cantonese or Mandarin)
Exclusion Criteria:
- Subjects with communication barriers owing to physical or cognitive conditions will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention group
Chat-based instant messaging support + Self-help booklet
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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.
Subjects will receive a standard self-help booklet on smoking relapse prevention.
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Active Comparator: Control group
SMS message support + Self-help booklet
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Subjects will receive a standard self-help booklet on smoking relapse prevention.
Subjects will receive regular SMS on generic smoking cessation for 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Biochemically-validated tobacco abstinence
Time Frame: Assessed at 6 months after randomisation
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Defined by an exhaled carbon monoxide level of 3 parts per million or below
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Assessed at 6 months after randomisation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Self-reported 6-month prolonged tobacco abstinence
Time Frame: Assessed at 6 months after randomisation
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Not more than five lapses permitted for 6 months after baseline
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Assessed at 6 months after randomisation
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Self-reported 7-day point-prevalence tobacco abstinence
Time Frame: Assessed at 3 months after randomisation
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Being completely smoke-free in the past 7 days
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Assessed at 3 months after randomisation
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Self-reported 7-day point-prevalence tobacco abstinence
Time Frame: Assessed at 6 months after randomisation
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Being completely smoke-free in the past 7 days
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Assessed at 6 months after randomisation
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Self-reported relapse rate
Time Frame: Assessed at 3 months after randomisation
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Defined as use of tobacco products for 7 consecutive days or longer
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Assessed at 3 months after randomisation
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Self-reported relapse rate
Time Frame: Assessed at 6 months after randomisation
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Defined as use of tobacco products for 7 consecutive days or longer
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Assessed at 6 months after randomisation
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in self-efficacy to quit smoking
Time Frame: Assessed at 3 months after randomisation
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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.
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Assessed at 3 months after randomisation
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Change in self-efficacy to quit smoking
Time Frame: Assessed at 6 months after randomisation
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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.
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Assessed at 6 months after randomisation
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Nicotine withdrawal
Time Frame: Assessed at 3 months after randomisation
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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.
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Assessed at 3 months after randomisation
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Nicotine withdrawal
Time Frame: Assessed at 6 months after randomisation
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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.
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Assessed at 6 months after randomisation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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):
- Luk TT, Cheung YTD, Chan HC, Fok PW, Ho KS, Sze CD, Lam TH, Wang MP. Mobile Chat Messaging for Preventing Smoking Relapse Amid the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2023 Jan 5;25(2):291-297. doi: 10.1093/ntr/ntac045.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 20-356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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