Interactive Communication Technologies and Nicotine Replacement Therapy Sampling for Smokers
NCT ID: NCT04001972
Last Updated: 2022-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
664 participants
INTERVENTIONAL
2019-08-19
2021-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Personalized Support Using Instant Messaging Applications to Increase Smoking Cessation
NCT03800719
Semi-personalized IM Smoking Cessation Interventions
NCT03574077
Mobile Chat Messaging for Smoking Relapse Prevention
NCT05370352
Quit Smoking: Optimizing Health Promotion Strategy
NCT06077058
Self-determination Plus Instant Messaging for Smokers With Cancer
NCT05643469
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention group
Brief advice (AWARD model) + NRT-S + IM Apps and Chatbot
Brief advice (AWARD model)
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-S
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 Chatbot
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.
Control group
Brief advice (AWARD model) + regular SMS
Brief advice (AWARD model)
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.
Regular SMS message
Regular SMS messages focus on general health and remind the importance of participating in the follow-up surveys and biochemical validation for quitting
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brief advice (AWARD model)
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-S
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 Chatbot
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
Regular SMS messages focus on general health and remind the importance of participating in the follow-up surveys and biochemical validation for quitting
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Exhaled carbon monoxide (CO) level of ≥ 4ppm.
3. Having smartphones and willing to install IM Apps and a Chatbot.
4. Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua).
Exclusion Criteria
2. Smokers who are using SC medication, NRT, other SC services or projects.
3. Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant \<6 months) or breastfeeding.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Food and Health Bureau, Hong Kong
OTHER_GOV
The University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Wang Man-Ping
Assistant Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Man Ping Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
School of Nursing, The University of Hong Kong
Hong Kong, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ICTNRT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.