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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03182790
Other study ID # QTW 2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 18, 2017
Est. completion date September 30, 2018

Study information

Verified date March 2019
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study will examine (1) the effectiveness of regular messages and semi-personalized instant messaging with AWARD brief advice and active referral to smoking cessation (SC) services 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 641,300 daily smokers (10.5%) 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.

Smoking cessation services in Hong Kong are under-used with most of the adult daily smokers (79.6%) who had never used smoking cessation services. Among these smokers, only 2.4% were willing to use the services. Our previous RCT in previous QTW Contest 2015 evaluated the effects of low-intensity active referral (LAR) vs. very brief general SC advice (VBA) on quitting. LAR included onsite AWARD counselling and collection of smokers' personal contact information for SC services providers to connect with the smokers. Findings at 3-month follow-up of this RCT suggested the LAR intervention resulted in significantly higher self-reported quit rate than VBA in the control group (18.7% vs. 14.0%. P<0.001). Our RCT in previous QTW Contest 2016 evaluated the effects of a higher intensity and personalized active referral (HAR) vs. low intensity text messaging (SMS) vs. very brief SC advice (VBA; control group) on encouraging smoking cessation (SC) service use and increasing the quit rate. Findings at 6-month follow-up of the QTW 2016 RCT showed that the intervention group with HAR had a significantly higher self-reported quit rate than VBA (the control group) (17.0% vs. 11.2%, P = 0.02). Text messaging group also had significantly higher self-reported quit rate than the control group (17.1 % vs. 11.2%, P = 0.02).

However, these SMS-based RCTs could not provide real-time responses from the counsellors, which might weaken the smokers' intention to quit and lower the intensity of social support. In the present proposal, we hope to enrich the SMS-based intervention by using social media such as WhatsApp or WeChat etc., which can provide an interactive platform and develop a semi-personalized interactive IM system that can tailor for the smokers according to their characteristics, needs and demand.

Therefore, the present study will examine (1) the effectiveness of regular messages and semi-personalized instant messaging with AWARD brief advice and active referral to smoking cessation (SC) services 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 Completed
Enrollment 1311
Est. completion date September 30, 2018
Est. primary completion date June 30, 2018
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 months

- 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

- Using a cell phone with instant messaging tool (e.g. WhatsApp, WeChat)

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Instant Messaging IM
Smokers can communicate with counsellors in real-time through instant messaging (social media). Our counsellors will trigger the conversation and invite the smokers to response after initial contact. Counsellors will keep contact with the smokers to offer help, positive encouragement, reflections and reminders about SC according to smokers' personal needs and to encourage them to seek SC services. Details of successfully booked SC appointment (e.g. SC services address, contact information, date, appointment number etc.) will be delivered to the smokers using IM. All smokers will receive a reminder-to-attend IM messages 1-3 days before the appointment date.
Regular messages
Regular messages, including: harm of smoking, benefit of smoking cessation, importance of adherence to smoking cessation appointment and encouragement on abstinence will be sent to smokers after initial contact via social media.
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).
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
Brief advice
Very brief, minimal and general smoking cessation advice
COSH booklet
A general smoking cessation self-help booklet
Placebo Messages
Placebo messages will be sent via smart phones (e.g. social media) to remind subjects to take follow-up calls before each follow-up time points.
Warning Leaflet
The leaflet will include the information about the health risks of smoking.

Locations

Country Name City State
Hong Kong Hong Kong Council on Smoking and Health (COSH) 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 Biochemical validated quit rate at 6-month follow-up Biochemically validated quit rates at 6-month in the two groups 6-month follow-up
Secondary Biochemical validated quit rate Biochemically validated quit rates at 3-month in the two groups 3-month follow-up
Secondary Smoking quit rate change from baseline at 3-month follow-up The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 3-month between the two groups 3-month follow-up
Secondary Smoking quit rate change from baseline at 6-month follow-up The primary outcomes are self-reported 7-day point prevalence (pp) quit rate at 6-month between the two groups 6-month follow-up
Secondary 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 3-month follow-up
Secondary 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 6-month follow-up
Secondary Smoking quit attempt change from baseline at 3-month follow-up Number of quit attempts at 3-month in the two groups 3-month follow-up
Secondary Smoking quit attempt change from baseline at 6-month follow-up Number of quit attempts at 6-month in the two groups 6-month follow-up
Secondary Quit rate for all subjects change from baseline at 3- and 6-month follow-up the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2017 3 and 6 months follow-up
Secondary Reduction rate for all subjects change from baseline at 3- and 6-month follow-up the above cessation and reduction outcomes of all subjects participating in Quit to Win contest 2017 3 and 6 months follow-up
Secondary Use of smoking cessation service Use of smoking cessation at 3 and 6 month follow-up in the two groups 3 and 6 months follow-up
Secondary Use of smoking cessation service for all subjects Use of smoking cessation service for all subjects participating in Quit to Win contest 2017 3 and 6 months follow-up
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