- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07649044
Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2026: Engagement-Focused GenAI-based Chatbot for Real-Time Smoking Cessation Support (QTW2026)
Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2026: Real-time Smoking Cessation Instant Messaging Support Using a Engagement-Focused Large Language Model (LLM)-Based Chatbot
The goal of this trial is to learn if chatbot-based instant messaging works to help smoking cessation in general adult smokers. It will also learn about the experience, attitude, and perception of using an LLM-based chatbot. The main questions it aims to answer are:
- Will an engagement-focused LLM-based chatbot smoking cessation intervention have a non-inferior validated abstinence rate than the control group?
- Will an LLM-based chatbot smoking cessation intervention have a non-inferior self-reported abstinence rate, smoking reduction rate, and smoking cessation services use rate than the control group?
Researchers will compare an LLM-based chatbot smoking-cessation intervention to a human-led instant messaging support group (brief advice based on AWARD and personalised active referral) to determine whether chatbot-based instant messaging support promotes smoking cessation.
Participants in the intervention group will receive:
- AWARD advice
- Personalised active referral
- 12 weeks of chatbot-based instant messaging support (via WhatsApp)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
- Comportamentale: Messaggi di promemoria
- Comportamentale: AWARD advice
- Comportamentale: Brief leaflet on health warning and smoking cessation
- Comportamentale: Referral card
- Comportamentale: Self-help smoking cessation booklet
- Comportamentale: Personalized active referral
- Comportamentale: 12 weeks of chatbot-based instant messaging support
- Comportamentale: 12 weeks of human-led instant messaging support
Descrizione dettagliata
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Man Ping Wang, PhD
- Numero di telefono: +852 3917 6636
- Email: mpwang@hku.hk
Backup dei contatti dello studio
- Nome: Yilan Wu
- Numero di telefono: +852 56497578
- Email: visspalan@connect.hku.hk
Luoghi di studio
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Hong Kong
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Hong Kong, Hong Kong, Hong Kong, 999077
- Hong Kong Council on Smoking and Health (COSH)
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Contatto:
- Man Ping Wang, PhD
- Numero di telefono: +852 3917 6636
- Email: mpwang@hku.hk
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Sub-investigatore:
- Shengzhi Zhao, PhD
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Sub-investigatore:
- Xiaoyun Xie, MPH
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Sub-investigatore:
- Mengyao Li, Mphil
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Contatto:
- Yilan Wu
- Numero di telefono: +852 56497578
- Email: visspalan@connect.hku.hk
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Investigatore principale:
- Man Ping Wang
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Sub-investigatore:
- Ziqiu Guo, PhD
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Sub-investigatore:
- Yilan Wu, MGH
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Hong Kong residents aged 18 years or above
- Smoke at least one cigarette (including heated tobacco products) per day or use an e-cigarette daily in the preceding 3 months
- Able to communicate in Cantonese (including reading and writing Chinese)
- Saliva cotinine level ≥30 ng/mL
- Intention to quit or reduce smoking
- Have WhatsApp installed
- Able to use WhatsApp for communication
Exclusion Criteria:
Currently participating in other smoking cessation programmes or using any smoking cessation drug
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Gruppo di intervento
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Messaggi WhatsApp sui promemoria del sondaggio di follow-up.
A brief (30-60 seconds) face-to-face or remote smoking cessation advice delivered using the validated AWARD model: Ask about smoking history; Warn about high health risks (accompanied by a health warning leaflet); Advise quitting as soon as possible and setting a quit date (to qualify for contest prizes); Refer to smoking cessation services using a referral card; Do it again - repeat the intervention at each follow-up, encouraging re-quitting after relapse or relapse prevention after success.
A two-sided, colour-printed A4 leaflet covering: (1) absolute risk of death from smoking; (2) full list of diseases caused by active and second-hand smoking; (3) ten pictorial warnings of health consequences on one page for maximum impact; (4) benefits of smoking cessation; and (5) simple encouraging messages to quit.
A three-folded card containing brief information and highlights of existing smoking cessation services in Hong Kong, contact methods, motivational messages, and strong supporting slogans.
A generic booklet provided covering: benefits of quitting, smoking-related diseases, methods to quit, how to handle withdrawal symptoms, a quitting declaration, and other practical tips.
Smokers will be introduced to various SC services in Hong Kong (via the referral card) and motivated to use them.
Well-trained SC ambassadors will assist smokers in choosing their favourite or most convenient type of service.
Research staff will assist participants in booking or re-booking the SC services at the 1- and 2-month follow-ups (after very brief questionnaire surveys).
Participants' contact information will be forwarded to SC service providers within 7 days, and providers are expected to contact participants within 1-2 weeks.
Research staff will also monitor participants' use of SC services at each follow-up (1-, 2-, 3-, and 6-month) and assist participants in booking or rebooking appointments if necessary at the 1- and 2-month follow-ups.
We shall liaise with the existing service providers and seek their assistance in supporting our smokers in a timely manner.
Participants in the intervention group will receive 12 weeks of instant messaging support delivered by an LLM-based chatbot (GPT-4o or newer) on WhatsApp, supporting text and audio input.
Using prompt engineering, agent techniques, and Retrieval-Augmented Generation, the chatbot delivers theory-based 5As/5Rs-structured interventions alongside freeform, on-demand support, with engagement features including personalisation, proactive check-ins, and interactive Quick Commands.
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Comparatore attivo: Gruppo di controllo
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Messaggi WhatsApp sui promemoria del sondaggio di follow-up.
A brief (30-60 seconds) face-to-face or remote smoking cessation advice delivered using the validated AWARD model: Ask about smoking history; Warn about high health risks (accompanied by a health warning leaflet); Advise quitting as soon as possible and setting a quit date (to qualify for contest prizes); Refer to smoking cessation services using a referral card; Do it again - repeat the intervention at each follow-up, encouraging re-quitting after relapse or relapse prevention after success.
A two-sided, colour-printed A4 leaflet covering: (1) absolute risk of death from smoking; (2) full list of diseases caused by active and second-hand smoking; (3) ten pictorial warnings of health consequences on one page for maximum impact; (4) benefits of smoking cessation; and (5) simple encouraging messages to quit.
A three-folded card containing brief information and highlights of existing smoking cessation services in Hong Kong, contact methods, motivational messages, and strong supporting slogans.
A generic booklet provided covering: benefits of quitting, smoking-related diseases, methods to quit, how to handle withdrawal symptoms, a quitting declaration, and other practical tips.
Smokers will be introduced to various SC services in Hong Kong (via the referral card) and motivated to use them.
Well-trained SC ambassadors will assist smokers in choosing their favourite or most convenient type of service.
Research staff will assist participants in booking or re-booking the SC services at the 1- and 2-month follow-ups (after very brief questionnaire surveys).
Participants' contact information will be forwarded to SC service providers within 7 days, and providers are expected to contact participants within 1-2 weeks.
Research staff will also monitor participants' use of SC services at each follow-up (1-, 2-, 3-, and 6-month) and assist participants in booking or rebooking appointments if necessary at the 1- and 2-month follow-ups.
We shall liaise with the existing service providers and seek their assistance in supporting our smokers in a timely manner.
Participants in the control group will receive 12 weeks of instant messaging support delivered by a trained human counsellor via WhatsApp.
Using the same theoretical frameworks as the chatbot intervention, the counsellor will provide real-time behavioural and psychosocial support grounded in the 5As/5Rs models, Motivational Interviewing (MI), and evidence-based Behaviour Change Techniques (BCTs).
The support will be personalised according to each participant's sociodemographic characteristics, smoking patterns, quit intentions, and plans.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Astinenza validata biochimicamente
Lasso di tempo: Controllo a 6 mesi
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Definito come livello di CO espirato <4ppm e livello di cotinina nella saliva ≤30 ng/ml
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Controllo a 6 mesi
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Astinenza validata biochimicamente
Lasso di tempo: Controllo a 3 mesi
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Definito come livello di CO espirato <4ppm e livello di cotinina nella saliva ≤30 ng/ml
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Controllo a 3 mesi
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Astinenza da prevalenza a 7 giorni auto-segnalata
Lasso di tempo: Follow-up di 3 e 6 mesi
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Fumatori che non fumarono nemmeno uno sbuffo nei 7 giorni precedenti il follow-up
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Follow-up di 3 e 6 mesi
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Riduzione auto-segnalata
Lasso di tempo: Follow-up da 1-, 2-, 3 e 6 mesi
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Definito da almeno il 50% di riduzione del numero giornaliero basale di sigarette
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Follow-up da 1-, 2-, 3 e 6 mesi
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Uso auto-segnalato del servizio di cessazione del fumo
Lasso di tempo: Follow-up da 1-, 2-, 3 e 6 mesi
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Uso del servizio di cessazione del fumo con follow-up da 1, 2-, 3 e 6 mesi.
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Follow-up da 1-, 2-, 3 e 6 mesi
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Prolonged abstinence
Lasso di tempo: 3-month and 6-month follow-ups
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Abstinence from smoking for 3 consecutive months at 3-month follow-up, or for 6 consecutive months at 6-month follow-up
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3-month and 6-month follow-ups
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Quit attempt
Lasso di tempo: 1-, 2-, 3-, and 6-month follow-ups
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Abstinence for at least 24 hours
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1-, 2-, 3-, and 6-month follow-ups
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Post-cessation weight change
Lasso di tempo: 6-month follow-up
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Self-reported change in body weight (in kilograms) from baseline to follow-up
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6-month follow-up
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Self-reported mental health conditions
Lasso di tempo: Baseline and 6-month follow-up
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Patient Health Questionnaire-4 (PHQ-4)
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Baseline and 6-month follow-up
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Self-reported smoking-related health conditions
Lasso di tempo: Baseline and 6-month follow-up
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Answer "Yes" to experiencing any smoking-related health condition during smoking cessation or reduction
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Baseline and 6-month follow-up
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Chatbot user experience
Lasso di tempo: 3-month follow-up
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Chatbot Usability Scale
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3-month follow-up
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Man Ping Wang, The University of Hong Kong
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- QTW2026
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