Chat-based Support for Preventing Smoking Relapse

Smoking Cessation Clinical Trial

Official title:

Chat-based Instant Messaging Support for Preventing Smoking Relapse in the Context of COVID-19 Outbreak: a Pilot Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409496
• Other study ID #: UW 20-356
• Status: Completed
• Phase: N/A
• Start date: June 2, 2020
• Est. completion date: January 22, 2021

Study information

• Verified date: March 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 22, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Smoking Cessation

Intervention

Behavioral:
• Chat-based instant messaging support
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.
• SMS message support
Subjects will receive regular SMS on generic smoking cessation for 3 months.
• Self-help booklet
Subjects will receive a standard self-help booklet on smoking relapse prevention.

Locations

Country	Name	City	State
Hong Kong	Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (5)

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. — View 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. — View 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. — View 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). pii: bjgpopen20X101067. doi: 10.3399/bjgpopen20X101067. Print 2020. Erratum in: BJGP Open. 2021 Jan 19;:. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in self-efficacy to quit smoking	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.	Assessed at 3 months after randomisation
Other	Change in self-efficacy to quit smoking	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.	Assessed at 6 months after randomisation
Other	Nicotine withdrawal	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.	Assessed at 3 months after randomisation
Other	Nicotine withdrawal	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.	Assessed at 6 months after randomisation
Primary	Biochemically-validated tobacco abstinence	Defined by an exhaled carbon monoxide level of 3 parts per million or below	Assessed at 6 months after randomisation
Secondary	Self-reported 6-month prolonged tobacco abstinence	Not more than five lapses permitted for 6 months after baseline	Assessed at 6 months after randomisation
Secondary	Self-reported 7-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 7 days	Assessed at 3 months after randomisation
Secondary	Self-reported 7-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 7 days	Assessed at 6 months after randomisation
Secondary	Self-reported relapse rate	Defined as use of tobacco products for 7 consecutive days or longer	Assessed at 3 months after randomisation
Secondary	Self-reported relapse rate	Defined as use of tobacco products for 7 consecutive days or longer	Assessed at 6 months after randomisation