Clinical trial NCT04399967: COVID-19 Brief Advice and Chat-based Support for Smoking Cessation Via "Quit to Win" Contest 2020
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
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Quit to Win
COVID-19
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Council on Smoking and Health
First posted: 2020-05-22
Enrollment: 1166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Biochemical validated quit rate
timeFrame: 3-month follow-up
measure: Biochemical validated quit rate
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Smoking quit rate change from baseline at 3-month follow-up
timeFrame: 3-month follow-up
measure: Smoking quit rate change from baseline at 6-month follow-up
timeFrame: 6-month follow-up
measure: Smoking reduction rate change from baseline at 3-month follow-up
timeFrame: 3-month follow-up
measure: Smoking reduction rate change from baseline at 6-month follow-up
timeFrame: 6-month follow-up
measure: Engagement in chat-based/text-based support
timeFrame: 3 and 6 months follow-up
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Council on Smoking and Health (COSH)
state: Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Man Ping Kelvin Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: