A Large Language Model-based Chatbot for Alcohol Reduction in Patients With Steatotic Liver Disease
A Large Language Model-based Chatbot for Alcohol Reduction Counseling in SLD Patients: A Pilot Randomized Controlled Trial
The goal of this pilot randomized controlled trial is to evaluate the trial feasibility and acceptability of LLM-based chatbot for reducing alcohol use among patients with Steatotic Liver Disease. Specific objectives include:
- To assess how many SLD patients accept the invitation to participate in the trial
- To assess the retention rate of the participants through 3 and 6 months after treatment initiation
- To assess the acceptability of the LLM-based chatbot in terms of participants' compliance and usability rating
- To estimate the intervention effect on alcohol reduction
- To explore the participants' perception and experiences in the chatbot
- To assess the feasibility of implementing Phosphatidylethanol (PEth) testing at the 3-month follow-up
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Hong Kong, 홍콩
- 모병
- Hong Kong Queen Mary Hospital
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연락하다:
- Man Ping Wang, Prof
- 전화번호: +85239176636
- 이메일: mpwang@hku.hk
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
1. Hong Kong residents aged 18 years or above 2. Diagnosed of SLD:
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Evidence of hepatic steatosis (fat accumulation in the liver) confirmed by imaging techniques such as ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), or liver biopsy
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Presence of metabolic dysfunction, indicated by at least one of the following:
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Overweight or obesity (body mass index [BMI] ≥25 kg/m²),
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Type 2 diabetes mellitus, ③Dyslipidemia (elevated triglycerides [≥150 mg/dL] or low high-density lipoprotein [HDL] cholesterol [<40 mg/dL for men, <50 mg/dL for women]), ④Hypertension (blood pressure ≥130/85 mmHg or use of antihypertensive medication).
- Metabolic syndrome as defined by established criteria (e.g., International Diabetes Federation [IDF], Adult Treatment Panel III [ATP III]) 3. AUDIT-C score of ≥ 3 (women) or ≥ 4 (men) 4. Intention to reduce/quit alcohol 5. Able to read and communicate in Chinese 6. Own a smartphone with internet access
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Exclusion Criteria:
- Diagnosed with mental disease or cognitive impairments, or
- Participating in other ongoing clinic trials
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: LLM-based chatbot
LLM-based chatbot + Alcohol Brief Intervention |
Over the three months following randomisation, an LLM-based chatbot will interact with each participant individually to deliver four personalized sessions of alcohol reduction information and advice, and participants will also be allowed to contact the chatbot at any time. Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet |
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활성 비교기: Telephone counseling
Telephone counseling + Alcohol Brief Intervention |
Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet Over the three months following randomisation, a trained counsellor will conduct four individual daytime telephone sessions with each participant to provide personalised information and advice on reducing alcohol consumption. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Retention rate
기간: 6 months after randomisation
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Number of participants completed the follow-up divided by the number of participants |
6 months after randomisation
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Weekly alcohol consumption
기간: 3 months after randomisation
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Assessed by questions 1 and 2 of AUDIT-C |
3 months after randomisation
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Recruitment rate
기간: Through recruitment completion, about 12 months
|
Number of participants divided by the number of eligible subjects |
Through recruitment completion, about 12 months
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Weekly alcohol consumption
기간: 6 months after randomisation
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Assessed by questions 1 and 2 of AUDIT-C |
6 months after randomisation
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AUDIT score and level
기간: 3 months after randomisation
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Assessed by the Alcohol Use Disorders Identification Test |
3 months after randomisation
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AUDIT score and level
기간: 6 months after randomisation
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Assessed by the Alcohol Use Disorders Identification Test |
6 months after randomisation
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Eligibility rate
기간: Through recruitment completion, about 12 months
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Number of eligible patients divided by the number of patients screened |
Through recruitment completion, about 12 months
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Frequency of binge drinking in the past 30 days
기간: 3 months after randomisation
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Self-reported |
3 months after randomisation
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Frequency of binge drinking in the past 30 days
기간: 6 months after randomisation
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Self-reported |
6 months after randomisation
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Frequency of heavy drinking in the past 30 days
기간: 3 months after randomisation
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Self-reported |
3 months after randomisation
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Frequency of heavy drinking in the past 30 days
기간: 6 months after randomisation
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Self-reported |
6 months after randomisation
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Planned drinking in the coming 30 days
기간: 3 months after randomisation
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Self-reported |
3 months after randomisation
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Planned drinking in the coming 30 days
기간: 6 months after randomisation
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Self-reported |
6 months after randomisation
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SLD
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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