Chat-based Support for Preventing Smoking Relapse

March 2, 2021 updated by: Tzu-Tsun Luk, The University of Hong Kong

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

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

Study Overview

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

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Intervention group
Chat-based instant messaging support + Self-help booklet

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.
Active Comparator: Control group
SMS message support + Self-help booklet
Subjects will receive a standard self-help booklet on smoking relapse prevention.
Subjects will receive regular SMS on generic smoking cessation for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemically-validated tobacco abstinence
Time Frame: Assessed at 6 months after randomisation
Defined by an exhaled carbon monoxide level of 3 parts per million or below
Assessed at 6 months after randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported 6-month prolonged tobacco abstinence
Time Frame: Assessed at 6 months after randomisation
Not more than five lapses permitted for 6 months after baseline
Assessed at 6 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Time Frame: Assessed at 3 months after randomisation
Being completely smoke-free in the past 7 days
Assessed at 3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence
Time Frame: Assessed at 6 months after randomisation
Being completely smoke-free in the past 7 days
Assessed at 6 months after randomisation
Self-reported relapse rate
Time Frame: Assessed at 3 months after randomisation
Defined as use of tobacco products for 7 consecutive days or longer
Assessed at 3 months after randomisation
Self-reported relapse rate
Time Frame: Assessed at 6 months after randomisation
Defined as use of tobacco products for 7 consecutive days or longer
Assessed at 6 months after randomisation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-efficacy to quit smoking
Time Frame: Assessed at 3 months after randomisation
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
Change in self-efficacy to quit smoking
Time Frame: Assessed at 6 months after randomisation
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
Nicotine withdrawal
Time Frame: Assessed at 3 months after randomisation
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
Nicotine withdrawal
Time Frame: Assessed at 6 months after randomisation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2020

Primary Completion (Actual)

January 22, 2021

Study Completion (Actual)

January 22, 2021

Study Registration Dates

First Submitted

May 26, 2020

First Submitted That Met QC Criteria

May 26, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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