A Large Language Model-based Chatbot for Alcohol Reduction in Patients With Metabolic Alcohol-Related Liver Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: LLM-based chatbot, Telephone counseling, Alcohol Brief Intervention.
- Кому может быть актуально
- Состояния в реестре: Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Alcohol-Related Liver Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Гонконг
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Large Language Model-based Chatbot for Alcohol Reduction Counseling in MetALD Patients: A Pilot Randomized Controlled Trial
Обзор
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 metabolic alcohol-related liver disease. Specific objectives include: 1. To assess how many MetALD patients accept the invitation to participate in the trial 2. To assess the retention rate of the participants through 3 and 6 months after treatment initiation 3. To assess the acceptability of the LLM-based chatbot in terms of participants' compliance and usability rating 4. To estimate the intervention effect on alcohol reduction 5. To explore the participants' perception and experiences in the chatbot
Вмешательства
- Поведенческое LLM-based chatbot
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. - Поведенческое Telephone counseling
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. - Поведенческое Alcohol Brief Intervention
Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet
Первичные конечные точки
- Recruitment rate [Срок оценки: Through recruitment completion, about 12 months]
- Retention rate [Срок оценки: 6 months after randomisation]
- Weekly alcohol consumption [Срок оценки: 3 months after randomisation]
Вторичные конечные точки (10)
- Eligibility rate [Срок оценки: Through recruitment completion, about 12 months]
- Weekly alcohol consumption [Срок оценки: 6 months after randomisation]
- Frequency of binge drinking in the past 30 days [Срок оценки: 3 months after randomisation]
- Frequency of binge drinking in the past 30 days [Срок оценки: 6 months after randomisation]
- Frequency of heavy drinking in the past 30 days [Срок оценки: 3 months after randomisation]
- Frequency of heavy drinking in the past 30 days [Срок оценки: 6 months after randomisation]
- AUDIT score and level [Срок оценки: 3 months after randomisation]
- AUDIT score and level [Срок оценки: 6 months after randomisation]
- Planned drinking in the coming 30 days [Срок оценки: 3 months after randomisation]
- Planned drinking in the coming 30 days [Срок оценки: 6 months after randomisation]
Критерии участия
Критерии включения
1\. Hong Kong residents aged 18 years or above 2. Diagnosed of MASLD:
- 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
- Presence of metabolic dysfunction, indicated by at least one of the following:
- Overweight or obesity (body mass index \[BMI\] ≥25 kg/m²),
- 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. Alcohol consumption: males who drink 210-420 g/week (≈263-525 ml), female who drink 140-350 g/week (≈175-438 ml) 4. Intention to reduce/quit alcohol 5. Able to read and communicate in Chinese 6. Own a smartphone with internet access
Критерии исключения
- Diagnosed with mental disease or cognitive impairments, or
- Participating in other ongoing clinic trials
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Гонконг · 1 центр
- Hong Kong Queen Mary Hospital — Гонконг
Идентификаторы
NCT: NCT07450144 · MetALD