Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation in Smokers Proactively Recruited From Smoking Hotspots in Hong Kong: a Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03800719
• Other study ID #: Personalized IM+referral
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: The University of Hong Kong
• Contact: Fleur Lee, MPhil
• Phone: +852-39176955
• Email: fleurlee[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the effect of personalized support using instant messaging application on smoking cessation in smokers proactively recruited from smoking hotspots in Hong Kong.

Description:

Detailed Description: With the advancement of information communication technologies (ICTs), instant messaging applications (IM Apps, e.g. WhatsApp and WeChat) can be used for providing synchronous, personalized, interactive interventions for health promotion. This study proposes to apply IM Apps for enhancing our tested brief smoking cessation (SC) intervention model from AWARD to e-AWARD (AWARD: Ask, Warn, Advise, Refer, Do-it-again,) without medications to increase SC in smokers proactively recruited in smoking hotspots in Hong Kong. Such smokers are the majority and have low quit rate. IM Apps allows trained SC advisors to proactively deliver personalized SC advices, response to smokers' needs promptly, and provide psychosocial support. No similar trials are found in PubMed, Cochrane Library and trial registries (ClinicalTrials.gov & ISRCTN) (except the pilot trial of this study). The aims of this study are as follows:

1. To assess the main effect of the personalized support using instant messaging applications (Intervention) vs. Control group on biochemical validated smoking abstinence at 6-month and 12-month.

2. To assess the effects on self-reported past 7-day abstinence, 24-week continuous abstinence, smoking reduction, self-efficacy of quitting, intention to quit, quit attempts and SC medications and services use at 6-month and 12-month.

3. To identify the mediators, which can inform mechanisms of the intervention on SC.

4. To evaluate the cost-effectiveness of the above interventions.

5. To understand the effects subjects' experience of IM support on SC using a qualitative study approach.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 696
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult smokers aged 18+ who smoke cigarette(s) daily.

• Exhaled carbon monoxide (CO) level of 4ppm or above.

• Having smartphones with IM Apps (WhatsApp) and have experience in using.

• Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).

Exclusion Criteria:

• Smokers who have psychiatric/psychological diseases or are on regular psychotropic medications.

• Smokers who are using SC medication, NRT, other SC services or projects.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• AWARD advice
At baseline, brief smoking cessation advice following AWARD model will be delivered to subjects within about 2 to 5 minutes: Ask about smoking history and habit Warn about the risks of smoking using a leaflet Advise to quit smoking as soon as possible and use nicotine replacement therapy (NRT) or SC services Refer subjects to free smoking cessation services in Hong Kong if they agree Do it again: smokers who have tried to quit but relapsed will be encouraged to quit again and those who have reduced smoking will be advised to further reduce or quit smoking
• Health warning leaflet
At baseline, an A5-sized leaflet will be given to subjects, which includes information about risks of smoking, pictures of smoking-related diseases, and smoking cessation services provided in Hong Kong.
• Active referral to smoking cessation (SC) services
At baseline, subjects will be encouraged to seek smoking cessation services in Hong Kong. If subjects agree, their contact information will be sent to the preferred service providers for a quick appointment and follow-up.
• Regular messages through Instant Messaging (IM)
A total of pre-set 26 messages will be sent to subjects through WhatsApp 12 weeks after baseline to remind the quit date and to encourage abstinence. Messages are tailored based on subjects' sociodemographic characteristics and smoking habit following Social Cognitive Theory and Transtheoretical Model. 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. The schedule will be adjusted according to the quit date and also smokers' requests. The format of regular messages will mainly be text-based but also include pictures, animations and videos.
• Psychosocial support and referral to SC services through IM
Personalized interactive text or voice conversation will be provided by trained smoking cessation advisors through WhatsApp for 3 months after baseline. Advisors will periodically proactively send messages to subjects to initiate the conversation (e.g. asking recent progress of smoking cessation) and deliver evidence-based advice. Advisors will also actively refer subjects, if they have expressed the need, to smoking cessation services providers. A standard operation algorithm for advisors used in the pilot feasibility trial will be modified for the use.
• Message on general health delivered by short message service (SMS)
After baseline, regular messages using SMS will be sent to subjects with similar frequency to Intervention group. The messages include information on general health and reminders on follow-up surveys and biochemical validation for quitting.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically-validated abstinence at 6-month	Defined as exhaled carbon monoxide <4ppm	6-month after baseline
Primary	Biochemically-validated abstinence at 12-month	Defined as exhaled carbon monoxide <4ppm	12-month after baseline
Secondary	Self-reported past 7-day abstinence	Self-reported no cigarette smoking (even a single puff) in the past 7 days	6-month and 12-month after baseline
Secondary	Self-reported 24-week continuous abstinence	Self-reported no cigarette smoking (even a single puff) in the past 24 weeks	6-month and 12-month after baseline
Secondary	Smoking reduction	Self-reported reduction in the number of cigarettes smoked daily by at least 50% of the baseline amount	6-month and 12-month after baseline
Secondary	Perceived importance, confidence and difficulties of quitting	Perceived importance, confidence and difficulties of quitting measured on a scale of 0-10 and a higher score indicates a stronger perception	6-month and 12-month after baseline
Secondary	Intention to quit	Any intention to quit smoking (yes/no) from baseline	6-month and 12-month after baseline
Secondary	Quit attempts	Number of quit attempts from baseline	6-month and 12-month after baseline
Secondary	Smoking cessation medication use	Any use of nicotine replacement therapy from baseline	6-month and 12-month after baseline
Secondary	Smocking cessation services use	Any use of counselling, hotline, SC clinics and other SC services from baseline	6-month and 12-month after baseline