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COVID-19 Brief Advice and Chat-based Support for Smoking Cessation Via "Quit to Win" Contest 2020 (QTW2020)

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ClinicalTrials.gov Identifier: NCT04399967
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : September 30, 2020
Sponsor:
Collaborator:
Hong Kong Council on Smoking and Health
Information provided by (Responsible Party):
Dr. Wang Man-Ping, The University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Chat-based support Behavioral: AWARD plus COVID-specific advice Behavioral: AWARD advice Behavioral: COVID-19 related health warning leaflet Behavioral: Health warning leaflet Behavioral: SMS-based support Behavioral: Referral card Behavioral: COSH Self-help smoking cessation booklet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 842 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: 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
Actual Study Start Date : June 13, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Personalized instant messaging (PIM) + COVID-19 specific advice + AWARD advice + COVID-related health warning leaflet + referral card + COSH booklet
Behavioral: Chat-based support
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, social support and behavioral capacity of quitting, and improve mental health during COVID-19 isolation or quarantine.

Behavioral: AWARD plus COVID-specific advice
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 Name: Ask, Warn, Advise, Refer, Do-it-again

Behavioral: COVID-19 related health warning leaflet
The 2-sided color printed A4 leaflet, which covers the risk of COVID-19 and smoking; hygienic advice related to COVID-19, and the most important messages to motivate smoking cessation

Behavioral: Referral card
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 Name: Smoking Cessation Service Card

Behavioral: COSH Self-help smoking cessation booklet
A general smoking cessation self-help booklet

Experimental: Control Group
Regular instant messaging (RIM) + AWARD advice + warning leaflet + referral card + COSH booklet
Behavioral: AWARD advice
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 Name: Ask, Warn, Advise, Refer, Do-it-again

Behavioral: Health warning leaflet
The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation.
Other Name: Brief leaflet on health warning and smoking cessation

Behavioral: SMS-based support
Participants will receive regular SMS with similar frequency to Intervention group but with generic information on smoking cessation.

Behavioral: Referral card
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 Name: Smoking Cessation Service Card

Behavioral: COSH Self-help smoking cessation booklet
A general smoking cessation self-help booklet




Primary Outcome Measures :
  1. Biochemical validated quit rate [ Time Frame: 3-month follow-up ]
    The primary outcomes are biochemically validated quit rates (exhaled CO < 4 ppm and salivary cotinine < 30 ng/ml) at 3-month in the two groups

  2. Biochemical validated quit rate [ Time Frame: 6-month follow-up ]
    The primary outcomes are biochemically validated quit rates (exhaled CO < 4 ppm and salivary cotinine < 30 ng/ml) at 6-month in the two groups


Secondary Outcome Measures :
  1. Smoking quit rate change from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups

  2. Smoking quit rate change from baseline at 6-month follow-up [ Time Frame: 6-month follow-up ]
    Self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups

  3. Smoking reduction rate change from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Rate of smoking reduction by at least half of baseline amount in the two groups

  4. Smoking reduction rate change from baseline at 6-month follow-up [ Time Frame: 6-month follow-up ]
    Rate of smoking reduction by at least half of baseline amount in the two groups

  5. Smoking quit attempt change from baseline at 3-month follow-up [ Time Frame: 3-month follow-up ]
    Number of quit attempts at 3-month in the two groups

  6. Smoking quit attempt change from baseline at 6-month follow-up [ Time Frame: 6-month follow-up ]
    Number of quit attempts at 6-month in the two groups

  7. Use of smoking cessation service [ Time Frame: 3 and 6 months follow-up ]
    Use of smoking cessation at 3 and 6 month follow-up in the two groups

  8. Engagement in chat-based/SMS-based support [ Time Frame: 3 and 6 months follow-up ]
    Self-reported engagement in chat-based/SMS-based support in the two groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  • Exhaled carbon monoxide (CO) 4 ppm or above; or 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

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): NCT04399967


Contacts
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Contact: Man Ping Kelvin Wang, PhD +852 3917 6636 mpwang@hku.hk
Contact: Xue Weng, PhD +852 3917 6304 xueweng@hku.hk

Locations
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China, Hong Kong
Hong Kong Council on Smoking and Health (COSH) Recruiting
Hong Kong, Hong Kong, China, 852
Contact: Fung Wong    +852 2180 5186      
Principal Investigator: Man Ping Kelvin Wang, PhD         
Sub-Investigator: Tai Hing Lam, MD, MSc         
Sub-Investigator: Ho Cheung William Li, PhD         
Sub-Investigator: Yee Tak Derek Cheung, PhD         
Sub-Investigator: Xue Weng, PhD         
Sub-Investigator: Yongda Wu, PhD         
Sponsors and Collaborators
The University of Hong Kong
Hong Kong Council on Smoking and Health
Investigators
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Principal Investigator: Man Ping Kelvin Wang, PhD The University of Hong Kong
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Responsible Party: Dr. Wang Man-Ping, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT04399967    
Other Study ID Numbers: QTW 2020
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 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 Dr. Wang Man-Ping, The University of Hong Kong:
Smoking cessation
Quit to Win
COVID-19