Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2019

Smoking Cessation Clinical Trial

Official title:

Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2019: Personalized Cocktail Interventions to Increase Abstinence: a Sequential, Multiple Assignment, Randomized Trial (SMART)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03992742
• Other study ID #: QTW 2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 21, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study will examine (1) effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence using a sequential multiple assignment randomised trial (SMART) 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.

Description:

Although smoking prevalence is decreasing in Hong Kong, there are still 615,000 daily cigarette smokers in Hong Kong in 2017 and half will be killed by smoking which accounts for over 7,000 deaths per year. Smoking also accounts for a large amount of medical cost, long-term care and productivity loss of US$688 million (0.6% Hong Kong GDP). Smoking is a highly addictive behavior and it is difficult for smokers with strong nicotine dependence to quit without assistance. On the other hand, reaching and helping the many smokers who have no intention to quit is a challenge, because they are unlikely to seek professional help from smoking cessation services.

The Quit and Win programme provides an opportunity to reach and encourage a large group of smokers to make quit attempt and maintain abstinence. The Quit and Win model posits that smokers participating in the contest will have higher motivation to quit with incentives and better social support. Studies have found that such quitting contests or incentive programs appeared to reach a large number of smokers and demonstrated a significantly higher quit rate for the quit and win group than for the control group.

We propose to use adaptive design for the QTW 2019 specifically a two-phase adaptive design, i.e., a sequential, multiple assignment, randomized trial (SMART) design. Optional cocktail cessation supports will be provided based on smokers' smoking status and preference. The supports, including multimedia messages, active referral plus financial incentive, phone counseling, social support and medications, are empirically evidence-supported and most have been used in our previous QTW interventions.

Therefore, the present study will examine (1) effectiveness of a combined intervention of AWARD advice, active referral, instant messaging and optional cocktail intervention to increase abstinence using a SMART design 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hong Kong residents aged 18 or above

• Smoke at least 1 cigarette per day in the past 3-month

• Able to communicate in Cantonese (including reading Chinese)

• Exhaled carbon monoxide (CO) 4 ppm or above, assessed by a validated CO Smokerlyzer.

• 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)

• Have participation in other smoking cessation programmes or services

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Initial phase: personalized instant messaging (PIM)
intervention Group participants will receive three months of personalized interaction through IM Apps (e.g. WhatsApp, WeChat). Our counsellors will trigger the conversation and encourage the participants to set a quit day. A total of pre-set 26 messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. These messages covered generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and encouragement to quit and use SC services. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PIM (subgroup C). Incomplete responders (smokers) will be randomized to continue PIM (subgroup B) or receive OCI (subgroup A).
• Second phase: optional cocktail interventions (OCI)
For incomplete respondents (subgroup A) randomized to OCI, the available intervention options include multi-media messages, active referral plus financial incentive, phone counseling, family/peer support and medications (NRT). Participants will be guided by cessation counsellors at 1-month follow-up telephone survey to choose any combination of OCI based on their preference. If OCI participants cannot be followed up at 1-month, they will receive multi-media messages by default.
• Initial phase: regular instant messaging (RIM)
Participants enrolled in the Control Group will receive regular messages via IM services (e.g. WhatsApp, WeChat) since initial contact and until 3-month after baseline with a tapering schedule: 1) Baseline to 4-week (1-month): 2 times/ week (8 in total); 2) 4-week to 12-week (2- & 3-month): 1 time/week (8 in total). SC messages will generally include benefits of SC, encouragement on abstinence and use of SC services, tips on avoiding/ handling craving and reminder of participating in telephone follow-up. A reminder to participate in the telephone follow-up will also be sent at 1-, 2-, 3- and 6-month, making up a total of 20 messages. At the end of the initial phase (1-month), complete responders (quitters) will continue to receive RIM (subgroup F). Incomplete responders (smokers) will be second randomized to continue RIM (subgroup E) or receive PIM (subgroup D). Those who are unable to follow up at 1-month will be considered as nonresponsive to the intervention.
• Second phase: personalized instant messaging (PIM)
For incomplete responders allocated to PIM (subgroup D), participants will receive the same intervention as the Group A delivered at the initial stage. Participants will receive two months of personalized interaction through IM application. Please refer to Intervention Group "Initial phase: personalized instant messaging (PIM)" for details.
• 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).
• Warning leaflet
The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
• 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
• COSH booklet
A general smoking cessation self-help booklet

Locations

Country	Name	City	State
Hong Kong	School of Nursing, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Hong Kong Council on Smoking and Health

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validated abstinence of PIM + OCI vs. RIM + PIM	PIM + OCI (subgroup A+B+C) vs. RIM + PIM (subgroup D+E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml)	6-month follow-up
Primary	Validated abstinence of OCI vs. RIM in incomplete responders	OCI (subgroup A) vs. RIM (subgroup E) in incomplete responders (those who are still smoking at 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml)	6-month follow-up
Secondary	Validated abstinence of PIM + OCI vs. RIM + PIM adjusted for potential imbalance of baseline characteristic	PIM + OCI (subgroup A+B+C) vs. RIM + PIM (subgroup D+E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) adjusted for potential imbalance of baseline characteristic.	6-month follow-up
Secondary	Validated abstinence of OCI vs. RIM in incomplete responders adjusted for potential imbalance of baseline characteristic	OCI (subgroup A) vs. RIM (subgroup E) in incomplete responders (those who are still smoking at 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) adjusted for potential imbalance of baseline characteristic	6-month follow-up
Secondary	Validated and self-reported abstinence of OCI vs. PIM in incomplete responders	OCI (subgroup A) vs. PIM (subgroup B) in incomplete responders (those who are still smoking with 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence	3- and 6-month follow-up
Secondary	Validated and self-reported abstinence of PIM vs. RIM in incomplete responders	PIM (subgroup D) vs. RIM (subgroup E) in incomplete responders (those who are still smoking with 1-month) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence	3- and 6-month follow-up
Secondary	Validated and self-reported abstinence of PIM vs. RIM	PIM (subgroup B+C) vs. RIM (subgroup E+F) on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence	3- and 6-month follow-up
Secondary	PIM intervention engagement on validated and self-reported abstinence	Difference between engagement of PIM intervention vs. no engagement of PIM intervention vs. RIM intervention on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence.; PIM intervention include subgroup B+C+D, RIM intervention include subgroup E+F.	3- and 6-month follow-up
Secondary	OCI intervention engagement on validated and self-reported abstinence	Difference between engagement of OCI intervention vs. no engagement of OCI intervention vs. engagement of PIM intervention vs. no engagement of PIM intervention vs. RIM intervention on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence.; OCI intervention include subgroup A, PIM intervention include subgroup B+C+D, RIM intervention include subgroup E+F.	3- and 6-month follow-up
Secondary	Smoking reduction rate change from baseline at 3- and 6-month follow-up	Rate of smoking reduction by at least half of baseline amount	3- and 6-month follow-up
Secondary	Smoking cessation service use	Use of smoking cessation service	3- and 6-month follow-up
Secondary	Nicotine independence (HSI) on abstinence and intervention engagement	Subgroup analyses of high nicotine independence vs. low nicotine independence on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence, and intervention engagement (use of PIM and/or OCI intervention)	3- and 6-month follow-up
Secondary	Intention to quit analyses on abstinence and intervention engagement	Subgroup analyses of high intention to quit vs. low intention to quit on validated abstinence (exhaled CO < 4 ppm and salivary cotinine < 10 ng/ml) and self-reported abstinence, and intervention engagement (use of OCI intervention and/or PIM intervention and/or RIM intervention).	3- and 6-month follow-up