Clinical trial NCT04409496: Chat-based Support for Preventing Smoking Relapse
Official title: Chat-based Instant Messaging Support for Preventing Smoking Relapse in the Context of COVID-19 Outbreak: a Pilot Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Instant messaging
Relapse prevention
WhatsApp
WeChat
Chat intervention
Chinese
Mobile health
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot trial aims to evaluate the effectiveness of chat-based instant messaging support in preventing smoking relapse in recent tobacco abstainers.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemically-validated tobacco abstinence
timeFrame: Assessed at 6 months after randomisation
Secondary outcomes:
measure: Self-reported 6-month prolonged tobacco abstinence
timeFrame: Assessed at 6 months after randomisation
measure: Self-reported 7-day point-prevalence tobacco abstinence
timeFrame: Assessed at 3 months after randomisation
measure: Self-reported 7-day point-prevalence tobacco abstinence
timeFrame: Assessed at 6 months after randomisation
measure: Self-reported relapse rate
timeFrame: Assessed at 3 months after randomisation
measure: Self-reported relapse rate
timeFrame: Assessed at 6 months after randomisation
Other outcomes:
measure: Change in self-efficacy to quit smoking
timeFrame: Assessed at 3 months after randomisation
measure: Change in self-efficacy to quit smoking
timeFrame: Assessed at 6 months after randomisation
measure: Nicotine withdrawal
timeFrame: Assessed at 3 months after randomisation
measure: Nicotine withdrawal
timeFrame: Assessed at 6 months after randomisation
Locations:
city: Hong Kong
country: Hong Kong
facility: Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
Study officials:
affiliation: The University of Hong Kong
name: Tzu Tsun Luk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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.
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: 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: 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.