Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation

September 26, 2019 updated by: Dr. Wang Man-Ping, The University of Hong Kong

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

696

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • Recruiting
        • School of Nursing, The University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention Group
AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, regular messages through Instant Messaging (IM), psychosocial support and referral to SC services through IM
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
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.
ACTIVE_COMPARATOR: Control Group
AWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, SMS message on general health
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
Behavioral: 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.
Behavioral: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemically-validated abstinence at 6-month
Time Frame: 6-month after baseline
Defined as exhaled carbon monoxide <4ppm
6-month after baseline
Biochemically-validated abstinence at 12-month
Time Frame: 12-month after baseline
Defined as exhaled carbon monoxide <4ppm
12-month after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported past 7-day abstinence
Time Frame: 6-month and 12-month after baseline
Self-reported no cigarette smoking (even a single puff) in the past 7 days
6-month and 12-month after baseline
Self-reported 24-week continuous abstinence
Time Frame: 6-month and 12-month after baseline
Self-reported no cigarette smoking (even a single puff) in the past 24 weeks
6-month and 12-month after baseline
Smoking reduction
Time Frame: 6-month and 12-month after baseline
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
Perceived importance, confidence and difficulties of quitting
Time Frame: 6-month and 12-month after baseline
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
Intention to quit
Time Frame: 6-month and 12-month after baseline
Any intention to quit smoking (yes/no) from baseline
6-month and 12-month after baseline
Quit attempts
Time Frame: 6-month and 12-month after baseline
Number of quit attempts from baseline
6-month and 12-month after baseline
Smoking cessation medication use
Time Frame: 6-month and 12-month after baseline
Any use of nicotine replacement therapy from baseline
6-month and 12-month after baseline
Smocking cessation services use
Time Frame: 6-month and 12-month after baseline
Any use of counselling, hotline, SC clinics and other SC services from baseline
6-month and 12-month after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 15, 2018

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

January 8, 2019

First Submitted That Met QC Criteria

January 9, 2019

First Posted (ACTUAL)

January 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Personalized IM+referral

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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