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Smoking CessationNCT03800719

Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation

A study testing AWARD advice, Health warning leaflet and Active referral to smoking cessation (SC) services in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
AWARD advice, Health warning leaflet and Active referral to smoking cessation (SC) services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
696 participants
Where
1 siteHong Kong
Study dates
15 Dec 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Smokers who have psychiatric/psychological diseases or are on regular psychotropic medications.
  • Smokers who are using SC medication, NRT, other SC services or projects.

Trial locations and contacts

1 site in 1 country.

Fleur Lee, MPhil contact

+852-39176955

fleurlee@hku.hk

Hong Kong1 site, 1 recruiting

  • School of Nursing, The University of Hong Kong

    Hong Kong, 000000

    Fleur Lee, MPhil, +852-39176955, fleurlee@hku.hk

    Recruiting

Other trials in Hong Kong

About this study

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

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.

Read the 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.
Being tested
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
Keywords
smoking cessation, active referral, IM
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AWARD adviceBehavioural

    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 leafletBehavioural

    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) servicesBehavioural

    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)Behavioural

    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 IMBehavioural

    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)Behavioural

    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.

Study groups in NCT03800719
Study groupRoleWhat they receive
Intervention GroupExperimentalAWARD 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
Receives: Behavioral: AWARD advice; Behavioral: Health warning leaflet; Behavioral: Active referral to smoking cessation (SC) services; Behavioral: Regular messages through Instant Messaging (IM); Behavioral: Psychosocial support and referral to SC services through IM
Control GroupActive comparatorAWARD advice, health warning leaflet, active referral to smoking cessation (SC) services, SMS message on general health
Receives: Behavioral: AWARD advice; Behavioral: Health warning leaflet; Behavioral: Active referral to smoking cessation (SC) services; Behavioral: Message on general health delivered by short message service (SMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemically-validated abstinence at 6-month

    Defined as exhaled carbon monoxide <4ppm

    Measured: 6-month after baseline

  2. Biochemically-validated abstinence at 12-month

    Defined as exhaled carbon monoxide <4ppm

    Measured: 12-month after baseline

Secondary outcomes (8)

  1. Self-reported past 7-day abstinence

    Self-reported no cigarette smoking (even a single puff) in the past 7 days

    Measured: 6-month and 12-month after baseline

  2. Self-reported 24-week continuous abstinence

    Self-reported no cigarette smoking (even a single puff) in the past 24 weeks

    Measured: 6-month and 12-month after baseline

  3. Smoking reduction

    Self-reported reduction in the number of cigarettes smoked daily by at least 50% of the baseline amount

    Measured: 6-month and 12-month after baseline

  4. 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

    Measured: 6-month and 12-month after baseline

  5. Intention to quit

    Any intention to quit smoking (yes/no) from baseline

    Measured: 6-month and 12-month after baseline

  6. Quit attempts

    Number of quit attempts from baseline

    Measured: 6-month and 12-month after baseline

  7. Smoking cessation medication use

    Any use of nicotine replacement therapy from baseline

    Measured: 6-month and 12-month after baseline

  8. Smocking cessation services use

    Any use of counselling, hotline, SC clinics and other SC services from baseline

    Measured: 6-month and 12-month after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2019
  2. Study start15 Dec 2018
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
696 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03800719
Sponsor's protocol ID
Personalized IM+referral
Status last verified
Sep 2019
First submitted
8 Jan 2019
Last updated
30 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lam TH, Cheung YT, Leung DY, Abdullah AS, Chan SS. Effectiveness of smoking reduction intervention for hardcore smokers. Tob Induc Dis. 2015 Apr 2;13(1):9. doi: 10.1186/s12971-015-0034-y. eCollection 2015.

    PubMed 25859176

  • Census and Statistics Department. Thematic Household Survey, Report No.59: Pattern of Smoking Hong Kong SAR: Hong Kong SAR Government. 2016. Available from: http://www.statistics.gov.hk/pub/B11302592016XXXXB0100.pdf.

  • Aveyard P, Begh R, Parsons A, West R. Brief opportunistic smoking cessation interventions: a systematic review and meta-analysis to compare advice to quit and offer of assistance. Addiction. 2012 Jun;107(6):1066-73. doi: 10.1111/j.1360-0443.2011.03770.x. Epub 2012 Feb 28.

    PubMed 22175545

  • Chan SS, Wong DC, Cheung YT, Leung DY, Lau L, Lai V, Lam TH. A block randomized controlled trial of a brief smoking cessation counselling and advice through short message service on participants who joined the Quit to Win Contest in Hong Kong. Health Educ Res. 2015 Aug;30(4):609-21. doi: 10.1093/her/cyv023. Epub 2015 Jun 25.

    PubMed 26116584

  • Chan SSC, Cheung YTD, Wan Z, Wang MP, Lam TH. Proactive and Brief Smoking Cessation Intervention for Smokers at Outdoor Smoking "Hotspots" in Hong Kong. J Cancer Educ. 2018 Apr;33(2):365-370. doi: 10.1007/s13187-016-1085-3.

    PubMed 27474113

  • Wang MP, Li WH, Cheung YT, Lam OB, Wu Y, Kwong AC, Lai VW, Chan SS, Lam TH. Brief Advice on Smoking Reduction Versus Abrupt Quitting for Smoking Cessation in Chinese Smokers: A Cluster Randomized Controlled Trial. Nicotine Tob Res. 2017 Dec 13;20(1):67-72. doi: 10.1093/ntr/ntx026.

    PubMed 28182243

  • Cheung YT, Wang MP, Li HC, Kwong A, Lai V, Chan SS, Lam TH. Effectiveness of a small cash incentive on abstinence and use of cessation aids for adult smokers: A randomized controlled trial. Addict Behav. 2017 Mar;66:17-25. doi: 10.1016/j.addbeh.2016.11.006. Epub 2016 Nov 10.

    PubMed 27863323

  • Chan SSC, Cheung YTD, Wong YMB, Kwong A, Lai V, Lam TH. A Brief Smoking Cessation Advice by Youth Counselors for the Smokers in the Hong Kong Quit to Win Contest 2010: a Cluster Randomized Controlled Trial. Prev Sci. 2018 Feb;19(2):209-219. doi: 10.1007/s11121-017-0823-z.

    PubMed 28755244

  • Cheung YTD, Lam TH, Li WHC, Wang MP, Chan SSC. Feasibility, Efficacy, and Cost Analysis of Promoting Smoking Cessation at Outdoor Smoking "Hotspots": A Pre-Post Study. Nicotine Tob Res. 2018 Nov 15;20(12):1519-1524. doi: 10.1093/ntr/ntx147.

    PubMed 28655173

  • Wang MP, Suen YN, Li WH, Lam CO, Wu SY, Kwong AC, Lai VW, Chan SS, Lam TH. Intervention With Brief Cessation Advice Plus Active Referral for Proactively Recruited Community Smokers: A Pragmatic Cluster Randomized Clinical Trial. JAMA Intern Med. 2017 Dec 1;177(12):1790-1797. doi: 10.1001/jamainternmed.2017.5793.

    PubMed 29059277

  • Wright J. Very brief advice can be effective in encouraging smokers to quit 2013 Available from: http://www.guidelinesinpractice.co.uk/jan_13_wright_smoking_jan13#.Vf927RGqqko.

  • Free C, Knight R, Robertson S, Whittaker R, Edwards P, Zhou W, Rodgers A, Cairns J, Kenward MG, Roberts I. Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial. Lancet. 2011 Jul 2;378(9785):49-55. doi: 10.1016/S0140-6736(11)60701-0.

    PubMed 21722952

  • Abroms LC, Boal AL, Simmens SJ, Mendel JA, Windsor RA. A randomized trial of Text2Quit: a text messaging program for smoking cessation. Am J Prev Med. 2014 Sep;47(3):242-50. doi: 10.1016/j.amepre.2014.04.010. Epub 2014 Jun 6.

    PubMed 24913220

  • Naughton F, Cooper S, Foster K, Emery J, Leonardi-Bee J, Sutton S, Jones M, Ussher M, Whitemore R, Leighton M, Montgomery A, Parrott S, Coleman T. Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit). Addiction. 2017 Jul;112(7):1238-1249. doi: 10.1111/add.13802. Epub 2017 May 2.

    PubMed 28239919

  • Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.

    PubMed 27060875

Questions about this trial

What is this clinical trial studying?

A study testing AWARD advice, Health warning leaflet and Active referral to smoking cessation (SC) services in people with Smoking Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fleur Lee, MPhil (+852-39176955, fleurlee@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically-validated abstinence at 6-month (time frame: 6-month after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03800719, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.

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