- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Comportemental: Messages de rappel
- Comportemental: AWARD advice
- Comportemental: Brief leaflet on health warning and smoking cessation
- Comportemental: Referral card
- Comportemental: Self-help smoking cessation booklet
- Comportemental: 12 weeks of chatbot-based instant messaging support
- Comportemental: 12 weeks of human-led instant messaging support
- Comportemental: Personalized active referral
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Man Ping Wang, PhD
- Numéro de téléphone: +852 3917 6636
- E-mail: mpwang@hku.hk
Sauvegarde des contacts de l'étude
- Nom: Yilan Wu
- Numéro de téléphone: +852 56497578
- E-mail: visspalan@connect.hku.hk
Lieux d'étude
-
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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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Contact:
- Man Ping Wang, PhD
- Numéro de téléphone: +852 3917 6636
- E-mail: mpwang@hku.hk
-
Sous-enquêteur:
- Shengzhi Zhao, PhD
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Sous-enquêteur:
- Xiaoyun Xie, MPH
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Sous-enquêteur:
- Mengyao Li, Mphil
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Contact:
- Yilan Wu
- Numéro de téléphone: +852 56497578
- E-mail: visspalan@connect.hku.hk
-
Chercheur principal:
- Man Ping Wang
-
Sous-enquêteur:
- Ziqiu Guo, PhD
-
Sous-enquêteur:
- Yilan Wu, MGH
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Sous-enquêteur:
- Patrick IP, MD, PhD
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Sous-enquêteur:
- Ning Huang, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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:
- Smokers who have communication barriers (either physical or cognitive)
- Smokers who are currently participating in other smoking cessation programs or services
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Groupe d'intervention
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Messages WhatsApp sur les rappels d'enquête de suivi.
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.
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.
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, at the 1- and 2-month follow-ups, assist participants in booking or rebooking appointments if necessary.
Investigators shall liaise with existing service providers and seek their assistance in promptly supporting our smokers.
|
|
Comparateur actif: Groupe de contrôle
|
Messages WhatsApp sur les rappels d'enquête de suivi.
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.
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.
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, at the 1- and 2-month follow-ups, assist participants in booking or rebooking appointments if necessary.
Investigators shall liaise with existing service providers and seek their assistance in promptly supporting our smokers.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Abstinence biochimiquement validée
Délai: Suivi de 6 mois
|
Défini comme un niveau de CO expiré < 4 ppm et un niveau de cotinine dans la salive ≤ 30 ng/ml
|
Suivi de 6 mois
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Abstinence biochimiquement validée
Délai: Suivi de 3 mois
|
Défini comme un niveau de CO expiré < 4 ppm et un niveau de cotinine dans la salive ≤ 30 ng/ml
|
Suivi de 3 mois
|
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Abstinence autodéclarée de 7 jours à l'abstinence
Délai: Suivi de 3 et 6 mois
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Les fumeurs qui n'ont pas fumé même une bouffée dans les 7 jours précédant le suivi
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Suivi de 3 et 6 mois
|
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Réduction autodéclarée
Délai: Suivi de 1, 2, 3 et 6 mois
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Défini par au moins 50% de réduction du nombre quotidien de cigarettes de base
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Suivi de 1, 2, 3 et 6 mois
|
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Utilisation autodéclarée du service de sevrage tabagique
Délai: Suivi de 1, 2, 3 et 6 mois
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Utilisation du service de sevrage tabagique à 1, 2, 3 et 6 mois de suivi.
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Suivi de 1, 2, 3 et 6 mois
|
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Prolonged abstinence
Délai: 3-month and 6-month follow-ups
|
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
Délai: 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
Délai: 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 smoking-related health conditions
Délai: Baseline and 6-month follow-up
|
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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Self-reported mental health conditions
Délai: Baseline and 6-month follow-up
|
Patient Health Questionnaire-4 (PHQ-4): The PHQ-4 is a 4-item ultra-brief screening tool for anxiety and depression that combines the GAD-2 and PHQ-2 subscales.
Each item is scored 0-3, with a total score of 0-12; subscale scores of 3 or higher indicate positive screening and warrant further clinical assessment.
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Baseline and 6-month follow-up
|
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Chatbot user experience
Délai: 3-month follow-up
|
Chatbot Usability Scale, or the 11-item Bot Usability Scale (BUS), is a validated questionnaire that evaluates chatbot usability across five dimensions (accessibility, function quality, conversation/information quality, privacy/security, and response time) using a 5-point Likert scale.
The total score (11-55) is the sum of all items; a higher total score indicates better overall usability and greater user satisfaction.
Higher scores on individual dimensions similarly reflect superior performance in those areas.
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3-month follow-up
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Man Ping Wang, The University of Hong Kong
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- QTW2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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