- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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)
연구 개요
상태
정황
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Man Ping Wang, PhD
- 전화번호: +852 3917 6636
- 이메일: mpwang@hku.hk
연구 연락처 백업
- 이름: Yilan Wu
- 전화번호: +852 56497578
- 이메일: visspalan@connect.hku.hk
연구 장소
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Hong Kong
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Hong Kong, Hong Kong, 홍콩, 999077
- Hong Kong Council on Smoking and Health (COSH)
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연락하다:
- Man Ping Wang, PhD
- 전화번호: +852 3917 6636
- 이메일: mpwang@hku.hk
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부수사관:
- Shengzhi Zhao, PhD
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부수사관:
- Xiaoyun Xie, MPH
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부수사관:
- Mengyao Li, Mphil
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연락하다:
- Yilan Wu
- 전화번호: +852 56497578
- 이메일: visspalan@connect.hku.hk
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수석 연구원:
- Man Ping Wang
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부수사관:
- Ziqiu Guo, PhD
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부수사관:
- Yilan Wu, MGH
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 개입 그룹
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후속 설문 조사 알림의 WhatsApp 메시지.
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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활성 비교기: 대조군
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후속 설문 조사 알림의 WhatsApp 메시지.
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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생화학적으로 검증된 금욕
기간: 6개월 추적
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호기 CO 수준 <4ppm 및 타액 코티닌 수준 ≤30ng/ml로 정의
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6개월 추적
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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생화학적으로 검증된 금욕
기간: 3개월 추적
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호기 CO 수준 <4ppm 및 타액 코티닌 수준 ≤30ng/ml로 정의
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3개월 추적
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자체보고 된 7 일 포인트 유병률 금욕
기간: 3 개월 및 6 개월 후속 조치
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후속 조치 전 7 일 동안 퍼프를 피우지 않은 흡연자
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3 개월 및 6 개월 후속 조치
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자체보고 감소
기간: 1-, 2-, 3- 및 6 개월 후속 조치
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기준선 일일 담배 수의 50% 이상 감소로 정의
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1-, 2-, 3- 및 6 개월 후속 조치
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흡연 중단 서비스의 자체보고 된 사용
기간: 1-, 2-, 3- 및 6 개월 후속 조치
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1-, 2-, 3 개 및 6 개월 후속 조치에서 금연 서비스 사용.
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1-, 2-, 3- 및 6 개월 후속 조치
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Prolonged abstinence
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 3-month follow-up
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Chatbot Usability Scale
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3-month follow-up
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공동 작업자 및 조사자
수사관
- 수석 연구원: Man Ping Wang, The University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
알림 메시지에 대한 임상 시험
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