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Chat-based Support for Preveting Smoking Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04409496
Recruitment Status : Active, not recruiting
First Posted : June 1, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Tzu-Tsun Luk, The University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Chat-based instant messaging support Behavioral: SMS message support Behavioral: Self-help booklet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chat-based Instant Messaging Support for Preventing Smoking Relapse in the Context of COVID-19 Outbreak: a Pilot Randomised Clinical Trial
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Chat-based instant messaging support + Self-help booklet
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.


Behavioral: Self-help booklet
Subjects will receive a standard self-help booklet on smoking relapse prevention.

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

Behavioral: Self-help booklet
Subjects will receive a standard self-help booklet on smoking relapse prevention.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Self-reported relapse rate [ Time Frame: Assessed at 3 months after randomisation ]
    Defined as use of tobacco products for 7 consecutive days or longer

  5. Self-reported relapse rate [ Time Frame: Assessed at 6 months after randomisation ]
    Defined as use of tobacco products for 7 consecutive days or longer


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409496


Locations
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Hong Kong
Tung Wah Group of Hospitals Integrated Centre on Smoking Cessation
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Tzu Tsun Luk, PhD, RN The University of Hong Kong
Publications:
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Responsible Party: Tzu-Tsun Luk, Research Assistant, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04409496    
Other Study ID Numbers: UW 20-356
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tzu-Tsun Luk, The University of Hong Kong:
Instant messaging
Relapse prevention
WhatsApp
WeChat
Chat intervention
Chinese
Mobile health
Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes