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Completed

NCT Number: NCT04001972

Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers

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).

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Nursing, The University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Brief advice (AWARD model)

Behavioral

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.

Other names: Ask, Warn, Advise, Refer and Do-it-again

NRT-S

Drug

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.

Other names: NRT sample

IM Apps and Chatbot

Behavioral

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 message

Behavioral

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

Primary outcomes

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

    Time frame: At 6-month follow-up

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

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

    Time frame: At 12-month follow-up

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

Secondary outcomes

  1. Self-reported 7-day point prevalence abstinence

    Time frame: At 6-month follow-up

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

  2. Self-reported 7-day point prevalence abstinence

    Time frame: At 12-month follow-up

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

  3. Self-reported past 24-week continuous abstinence

    Time frame: At 6-month follow-up

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

  4. Self-reported past 24-week continuous abstinence

    Time frame: At 12-month follow-up

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

  5. Planned quit day

    Time frame: At 6-month follow-up

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

  6. Planned quit day

    Time frame: At 12-month follow-up

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

  7. Change in number of quit attempts from baseline

    Time frame: At 6-month follow-up

    Defined by abstinence for at least 24 hours from baseline

  8. Change in number of quit attempts from baseline

    Time frame: At 12-month follow-up

    Defined by abstinence for at least 24 hours from baseline

  9. Change in smoking reduction rate from baseline

    Time frame: At 6-month follow-up

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

  10. Change in smoking reduction rate from baseline

    Time frame: At 12-month follow-up

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

  11. Change in micotine addiction level from baseline

    Time frame: At 6-month follow-up

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

  12. Change in micotine addiction level from baseline

    Time frame: At 12-month follow-up

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

  13. Any access to a smoking cessation service

    Time frame: At 6-month follow-up

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

  14. Any access to a smoking cessation service

    Time frame: At 12-month follow-up

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

  15. Any use of nicotine replacement therapy

    Time frame: At 6-month follow-up

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

  16. Any use of nicotine replacement therapy

    Time frame: At 12-month follow-up

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

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

    Time frame: At 12-month follow-up

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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Food and Health Bureau, Hong Kong

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 28, 2019
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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