- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04399967
COVID-19 Brief Advice and Chat-based Support for Smoking Cessation Via "Quit to Win" Contest 2020 (QTW2020)
Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2020: a Single-blind Randomized Controlled Trial on COVID-19 Related Brief Advice and Personalized Chat-based Intervention for Smoking Cessation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Smoking is detrimental to the immune system and can cause respiratory tract infection. Growing evidence has suggested that compared to non-smokers, COVID-19 patients who have a history of smoking are at a higher risk of developing severe respiratory and cardiovascular symptoms, consequently may require mechanical ventilation and intensive care. A case series of 1,099 COVID-19 patients in China has found that ever smokers, compared with never smokers, were more likely to have severe COVID-19 disease upon hospital admission and be admitted to intensive care unit, need to use mechanical ventilation, and die. The result is corroborated by a multivariable analysis of 78 COVID-19 pneumonia cases in China, which identified smoking as the only preventable risk factor for disease progression. While the link between smoking and the COVID-19 needs further research, smokers appear to be at a greater risk of suffering from serious symptoms due to COVID-19.
The practice of smoking might also predispose smokers to COVID-19 infection. Smoking behavior is characterized by inhalation and the hand-to-mouth movements which increase the possibility of transmission of virus from contaminated fingers and cigarettes to mouth. In Hong Kong, where smoking is banned in indoor public areas and workplace, smokers often gather and smoke at smoking hotspots outdoor, where ashtrays are available. This increases their risk of infection since the smokers are in close contact with each other and have to remove their mask to smoke. Exhaling smoke also aids the spreading the virus in the air. However, misleading information that smoking can prevent COVID-19 infection is widespread on social media.
Public health strategies (e.g., social distancing, staying at home and working from home) may motivate some smokers to reduce or to quit smoking due to the inconvenience to smoke indoor and to buy cigarettes from retail outlets. However, home confinement may result in social isolation and psychological distress (anxiety and stress) both increasing the need for smoking. Some smokers who are not used to smoke at home might be prompted to smoke at home to cope with their craving during lockdown or work from home, which may also expose their family members from second-hand smoke.
Our RCT in QTW Contest 2017 evaluated the effectiveness of a chat-based intervention delivered through a mobile instant messaging application (WhatsApp) plus active referral to SC services to increase quitting. Chat-based intervention resulted in higher abstinence rate compared with the control group at 6-month follow-up. In QTW Contest 2019, we evaluated the effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence. The preliminary result showed that the personalized instant messaging (PIM) group and regular instant messaging (RIM) group had similar abstinence rate at 6-month follow-up.
Therefore, the present study will examine (1) the effectiveness of a combined brief advice and personalized chat-based support on COVID-19 related smoking messages and (2) explore the use of CBPR model to build capacity and to engage community partners in taking on this important public health issue for sustainability in the community. In addition, a process evaluation will be conducted to assess the effectiveness of the recruitment activity and how it is linked with the overall program outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong
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Hong Kong, Hong Kong, China, 852
- Hong Kong Council on Smoking and Health (COSH)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hong Kong residents aged 18 or above
- Smoke at least 1 tobacco stick per day or use e-cigarette daily in the past 3-month
- Able to communicate in Cantonese (including reading Chinese)
- Saliva cotinine 30 ng/ml or above
- Intent to quit / reduce smoking
- Able to use instant messaging tool (e.g., WhatsApp, WeChat) for communication.
Exclusion Criteria:
- Smokers who have communication barrier (either physically or cognitively)
- Smokers who are currently participating in other SC programmes or services
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
Chat-based support+ COVID-19 specific advice + AWARD advice + COVID-related health warning leaflet + referral card + COSH booklet
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Participants will receive three months of chat-based support through IM apps (e.g.
WhatsApp, WeChat).
The regular messages and instant messaging on psychosocial support aim to provide hygienic advice to reduce the risk of exposure to SARS-cov2, increase self-efficacy and confidence, and social support and behavioral capacity of quitting.
Ask about smoking history, Warn about the risks associated with the COVID-19 and smoking (with a COVID-related health warning leaflet), Advise to quit as soon as possible during the COVID-19 pandemic, Refer smokers to SC services (with a referral card, see below for information), and Do it again: to repeat the intervention
Other Names:
The 2-sided color printed A4 leaflet, which covers the risk of COVID-19 and smoking and the most important messages to motivate smoking cessation
The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans.
Other Names:
A general smoking cessation self-help booklet
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Experimental: Control Group
Text-based support + AWARD advice + warning leaflet + referral card + COSH booklet
|
The 3-folded "Smoking Cessation Services" card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans.
Other Names:
A general smoking cessation self-help booklet
Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
Other Names:
The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation.
Other Names:
Participants will receive regular SMS with similar frequency to Intervention group but with generic information on smoking cessation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical validated quit rate
Time Frame: 3-month follow-up
|
The primary outcomes are biochemically validated quit rates (exhaled CO < 4 ppm or salivary cotinine < 30 ng/ml) at 3-month in the two groups
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3-month follow-up
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Biochemical validated quit rate
Time Frame: 6-month follow-up
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The primary outcomes are biochemically validated quit rates (exhaled CO < 4 ppm or salivary cotinine < 30 ng/ml) at 6-month in the two groups
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6-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking quit rate change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
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Self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups
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3-month follow-up
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Smoking quit rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
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Self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups
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6-month follow-up
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Smoking reduction rate change from baseline at 3-month follow-up
Time Frame: 3-month follow-up
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Rate of smoking reduction by at least half of baseline amount in the two groups
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3-month follow-up
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Smoking reduction rate change from baseline at 6-month follow-up
Time Frame: 6-month follow-up
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Rate of smoking reduction by at least half of baseline amount in the two groups
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6-month follow-up
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Engagement in chat-based/text-based support
Time Frame: 3 and 6 months follow-up
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Self-reported engagement in chat-based/SMS-based support in the two groups
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3 and 6 months follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Man Ping Kelvin Wang, PhD, The University of Hong Kong
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
- QTW 2020
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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