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

Primary Purpose

Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chat-based support
AWARD plus COVID-specific advice
AWARD advice
COVID-19 related health warning leaflet
Health warning leaflet
SMS-based support
Referral card
COSH Self-help smoking cessation booklet
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Smoking Cessation focused on measuring Smoking cessation, Quit to Win, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hong Kong Council on Smoking and Health (COSH)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Control Group

Arm Description

Chat-based support+ COVID-19 specific advice + AWARD advice + COVID-related health warning leaflet + referral card + COSH booklet

Text-based support + AWARD advice + warning leaflet + referral card + COSH booklet

Outcomes

Primary Outcome Measures

Biochemical validated quit rate
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
Biochemical validated quit rate
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

Secondary Outcome Measures

Smoking quit rate change from baseline at 3-month follow-up
Self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups
Smoking quit rate change from baseline at 6-month follow-up
Self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups
Smoking reduction rate change from baseline at 3-month follow-up
Rate of smoking reduction by at least half of baseline amount in the two groups
Smoking reduction rate change from baseline at 6-month follow-up
Rate of smoking reduction by at least half of baseline amount in the two groups
Engagement in chat-based/text-based support
Self-reported engagement in chat-based/SMS-based support in the two groups

Full Information

First Posted
May 19, 2020
Last Updated
May 22, 2023
Sponsor
The University of Hong Kong
Collaborators
Hong Kong Council on Smoking and Health
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1. Study Identification

Unique Protocol Identification Number
NCT04399967
Brief Title
COVID-19 Brief Advice and Chat-based Support for Smoking Cessation Via "Quit to Win" Contest 2020
Acronym
QTW2020
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Hong Kong Council on Smoking and Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation
Keywords
Smoking cessation, Quit to Win, COVID-19

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Chat-based support+ COVID-19 specific advice + AWARD advice + COVID-related health warning leaflet + referral card + COSH booklet
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Text-based support + AWARD advice + warning leaflet + referral card + COSH booklet
Intervention Type
Behavioral
Intervention Name(s)
Chat-based support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
AWARD plus COVID-specific advice
Other Intervention Name(s)
Ask, Warn, Advise, Refer, Do-it-again
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
AWARD advice
Other Intervention Name(s)
Ask, Warn, Advise, Refer, Do-it-again
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
COVID-19 related health warning leaflet
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Health warning leaflet
Other Intervention Name(s)
Brief leaflet on health warning and smoking cessation
Intervention Description
The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
SMS-based support
Intervention Description
Participants will receive regular SMS with similar frequency to Intervention group but with generic information on smoking cessation.
Intervention Type
Behavioral
Intervention Name(s)
Referral card
Other Intervention Name(s)
Smoking Cessation Service Card
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
COSH Self-help smoking cessation booklet
Intervention Description
A general smoking cessation self-help booklet
Primary Outcome Measure Information:
Title
Biochemical validated quit rate
Description
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
Time Frame
3-month follow-up
Title
Biochemical validated quit rate
Description
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
Time Frame
6-month follow-up
Secondary Outcome Measure Information:
Title
Smoking quit rate change from baseline at 3-month follow-up
Description
Self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups
Time Frame
3-month follow-up
Title
Smoking quit rate change from baseline at 6-month follow-up
Description
Self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups
Time Frame
6-month follow-up
Title
Smoking reduction rate change from baseline at 3-month follow-up
Description
Rate of smoking reduction by at least half of baseline amount in the two groups
Time Frame
3-month follow-up
Title
Smoking reduction rate change from baseline at 6-month follow-up
Description
Rate of smoking reduction by at least half of baseline amount in the two groups
Time Frame
6-month follow-up
Title
Engagement in chat-based/text-based support
Description
Self-reported engagement in chat-based/SMS-based support in the two groups
Time Frame
3 and 6 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Man Ping Kelvin Wang, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hong Kong Council on Smoking and Health (COSH)
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
852
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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