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Smoking CessationNCT04001972

Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers

A study testing Brief advice (AWARD model), NRT-S and IM Apps and Chatbot in people with Smoking Cessation and Tobacco Use Cessation, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S). 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, Tobacco Use Cessation
What is being tested?
Brief advice (AWARD model), NRT-S and IM Apps and Chatbot
Could I receive a placebo?
No, everyone receives an active treatment
How many people
664 participants
Where
1 siteHong Kong
Study dates
19 Aug 2019to 30 Sep 2021
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+ years who smoke cigarette(s) daily.
  • Exhaled carbon monoxide (CO) level of ≥ 4ppm.
  • Having smartphones and willing to install IM Apps and a Chatbot.
  • Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).

Who cannot join

  • Smokers who have psychiatric/psychological diseases/on regular psychotropic medications.
  • Smokers who are using SC medication, NRT, other SC services or projects.
  • Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant <6 months) or breastfeeding.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • School of Nursing, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Intervention Combining Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Proactively Recruited Smokers in Smoking Hotspots: a Pragmatic Randomized Controlled Trial

Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S).

Read the detailed description

Objectives: Brief advice combined with active referral to smoking cessation (SC) services increases quitting. We aim to strengthen the effect of combined intervention by using interactive communication technologies and nicotine replacement therapy sampling (NRT-S).

Design and subjects: Pragmatic, individual randomized controlled trial in 664 daily smokers proactively recruited in smoking hotspots in Hong Kong.

Interventions: Subjects in the Intervention group will receive face-to-face brief advice (including SC services referral) using AWARD model and 1-week free NRT sample (NRT-S) at baseline; and 12-week personalized behavioral support using interactive communication technologies (include regular tailored messages on abstinence, and synchronous IM Apps [e.g. WhatsApp] conversation with trained SC advisors and a Chatbot). Subjects in the Control group will receive the same AWARD advice without NRT-S at baseline, and regular short-message-service messages on general health and reminders to participate in follow-up.

Main outcome measures: Primary outcomes are carbon monoxide validated smoking abstinence at 6-month and 12-month. Secondary outcomes include self-reported past 7-day abstinence, smoking reduction, quit attempt, SC services use, NRT use, self-efficacy on quitting and quality of life.

Data analysis: Intention-to-treat and cost-effectiveness analyses will be conducted. Mediation analyses will explore the underlying mechanisms of Chatbot and IM Apps behavioral support to promote quitting. Individual interviews with quitters and non-quitters, and content analysis of Chatbot/IM Apps will be conducted to have in-depth understanding on the effects of intervention on various outcomes.

Expected results: The Intervention group will have statistically significant higher validated smoking abstinence rates than the Control group at 6-month and 12-month.

Being tested
Brief advice (AWARD model), NRT-S, IM Apps and Chatbot, Regular SMS message
Keywords
tobacco dependence treatment, combined brief intervention, AWARD advice, active referral, nicotine replacement therapy, information and communication technologies
Medical subject headings
Smoking Cessation, Tobacco Use Cessation

What participants receive

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

  • Brief advice (AWARD model)Behavioural

    Also called Ask, Warn, Advise, Refer and Do-it-again

    Ask: smoking habit, quit intention and attempt, smoking reduction intention, previous quitting experience including NRT and SC use.

    Warn: smokers will be orally warned about the harms of smoking and receive a A5-sized leaflet, which includes some shocking pictures of smoking-related diseases, and SC services information.

    Advise: smokers will be advised to quit as soon as possible and use NRT or SC services.

    Refer: smokers will be encouraged to seek SC services for free NRT or other SC services. Those who agreed will be actively referred to their preferred SC services. The collected contact information with consent will be sent to the SC services providers for a quick appointment and follow-up.

    Do-it-again: Relapsed smokers (identified during follow-ups and IM conversation) will receive the "Advise" and "Refer" intervention.

  • NRT-SDrug

    Also called NRT sample

    One-week free NRT (gum or patch) will be provided with dosage based on time to first cigarette smoking after waking up in the morning and previous NRT use (standard practice and according to specific NRT product instructions). Subjects who have first cigarette <30 minutes in the morning or have previously used NRT, will receive 4mg nicotine gum or 21mg nicotine patch. Those who have first cigarette >30 minutes after waking up and have not previously used NRT will receive 2mg nicotine gum or 14mg nicotine patch. NRT use and potential side effects will be briefly explained orally based on standardized script according to the product instructions. An NRT use card containing reminders of NRT use and potential side effects will be given.

  • IM Apps and ChatbotBehavioural

    Twelve-week personalized behavioral support will be delivered using interactive communication technologies using (1) regular tailored messages on abstinence, and (2) synchronous IM Apps conversation with trained SC advisors, and (3) a Chatbot: A Chatbot will be built using open source NLP and machine intelligence platforms. The unstructured text data from our previous study (ClinicalTrials.gov ID: NCT03182790) will be used to train the proposed Chatbot. We will draft responses for each identified question. The final version will be incorporated with Application Programming Interface (API) integration into user-friendly apps (iOS/Android/web app) with a backend server support and continuous data collection for potential bigdata analysis.

  • Regular SMS messageBehavioural

    Regular SMS messages focus on general health and remind the importance of participating in the follow-up surveys and biochemical validation for quitting

Study groups in NCT04001972
Study groupRoleWhat they receive
Intervention groupExperimentalBrief advice (AWARD model) + NRT-S + IM Apps and Chatbot
Receives: Behavioral: Brief advice (AWARD model); Drug: NRT-S; Behavioral: IM Apps and Chatbot
Control groupActive comparatorBrief advice (AWARD model) + regular SMS
Receives: Behavioral: Brief advice (AWARD model); Behavioral: Regular SMS message

What is being measured

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

  1. Biochemically validated abstinence of NRT-S +IM Apps and Chatbot vs. regular SMS

    NRT-S +IM Apps and Chatbot vs. regular SMS on validated abstinence defined as exhaled carbon monoxide <4ppm

    Measured: At 6-month follow-up

  2. Biochemically validated abstinence of NRT-S +IM Apps and Chatbot vs. regular SMS

    NRT-S +IM Apps and Chatbot vs. regular SMS on validated abstinence defined as exhaled carbon monoxide <4ppm

    Measured: At 12-month follow-up

Secondary outcomes (17)

  1. Self-reported 7-day point prevalence abstinence

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

    Measured: At 6-month follow-up

  2. Self-reported 7-day point prevalence abstinence

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

    Measured: At 12-month follow-up

  3. Self-reported past 24-week continuous abstinence

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

    Measured: At 6-month follow-up

  4. Self-reported past 24-week continuous abstinence

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

    Measured: At 12-month follow-up

  5. Planned quit day

    Planned quit day with responses "within 7 days/within 30 days/within 60 days/undecided"

    Measured: At 6-month follow-up

  6. Planned quit day

    Planned quit day with responses "within 7 days/within 30 days/within 60 days/undecided"

    Measured: At 12-month follow-up

  7. Change in number of quit attempts from baseline

    Defined by abstinence for at least 24 hours from baseline

    Measured: At 6-month follow-up

  8. Change in number of quit attempts from baseline

    Defined by abstinence for at least 24 hours from baseline

    Measured: At 12-month follow-up

  9. Change in smoking reduction rate from baseline

    Defined by at least 50% reduction in baseline daily number of cigarettes

    Measured: At 6-month follow-up

  10. Change in smoking reduction rate from baseline

    Defined by at least 50% reduction in baseline daily number of cigarettes

    Measured: At 12-month follow-up

  11. Change in micotine addiction level from baseline

    Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)

    Measured: At 6-month follow-up

  12. Change in micotine addiction level from baseline

    Assessed by Heaviness of Smoking Index (range 0 to 6 with higher score indicating greater nicotine dependence)

    Measured: At 12-month follow-up

  13. Any access to a smoking cessation service

    Any access to a smoking cessation service with responses "yes/no"

    Measured: At 6-month follow-up

  14. Any access to a smoking cessation service

    Any access to a smoking cessation service with responses "yes/no"

    Measured: At 12-month follow-up

  15. Any use of nicotine replacement therapy

    Any use of nicotine replacement therapy with responses "yes/no"

    Measured: At 6-month follow-up

  16. Any use of nicotine replacement therapy

    Any use of nicotine replacement therapy with responses "yes/no"

    Measured: At 12-month follow-up

  17. Change in quality-adjusted life year (QALY)

    Change in quality-adjusted life year (QALY) will be estimated using the validated Chinese five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)

    Measured: At 12-month follow-up

Timeline

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

  1. First posted28 Jun 2019
  2. Study start19 Aug 2019
  3. Primary completion8 May 2021
  4. Study completion30 Sep 2021

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
Single blind
Who is masked
Outcomes assessor
Enrolment
664 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04001972
Sponsor's protocol ID
ICTNRT
Status last verified
May 2022
First submitted
12 Jun 2019
Last updated
23 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo N, Luk TT, Wu YS, Guo Z, Chu JCL, Cheung YTD, Chan CHH, Kwok TTO, Wong VYL, Wong CKH, Lee JJ, Kwok YK, Viswanath K, Lam TH, Wang MP. Effect of mobile interventions with nicotine replacement therapy sampling on long-term smoking cessation in community smokers: A pragmatic randomized clinical trial. Tob Induc Dis. 2023 Mar 24;21:44. doi: 10.18332/tid/160168. eCollection 2023.

    PubMed 36969982

Questions about this trial

What is this clinical trial studying?

A study testing Brief advice (AWARD model), NRT-S and IM Apps and Chatbot in people with Smoking Cessation and Tobacco Use 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 3 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: finished, as of the sponsor's last update on 23 May 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemically validated abstinence of NRT-S +IM Apps and Chatbot vs. regular SMS (time frame: At 6-month follow-up). 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 NCT04001972, which also lists 1 linked publication.

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 23 May 2022.

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