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
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Hong Kong、香港
- 募集
- Hong Kong Queen Mary Hospital
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コンタクト：
- Man Ping Wang, Prof
- 電話番号：+85239176636
- メール：mpwang@hku.hk
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Retention rate
時間枠：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
時間枠：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
時間枠：Through recruitment completion, about 12 months
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Number of participants divided by the number of eligible subjects |
Through recruitment completion, about 12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Weekly alcohol consumption
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：6 months after randomisation
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Self-reported |
6 months after randomisation
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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