A Large Language Model-based Chatbot for Alcohol Reduction Counseling in MetALD Patients: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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:
- To assess how many MetALD 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Hong Kong residents aged 18 years or above
- •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])
- •Alcohol consumption: males who drink 210-420 g/week (≈263-525 ml), female who drink 140-350 g/week (≈175-438 ml)
- •Intention to reduce/quit alcohol
- •Able to read and communicate in Chinese
- •Own a smartphone with internet access
排除标准
- •Diagnosed with mental disease or cognitive impairments, or
- •Participating in other ongoing clinic trials
研究组 & 干预措施
Telephone counseling
Telephone counseling + Alcohol Brief Intervention
干预措施: Telephone counseling (Behavioral)
Telephone counseling
Telephone counseling + Alcohol Brief Intervention
干预措施: Alcohol Brief Intervention (Behavioral)
LLM-based chatbot
LLM-based chatbot + Alcohol Brief Intervention
干预措施: LLM-based chatbot (Behavioral)
LLM-based chatbot
LLM-based chatbot + Alcohol Brief Intervention
干预措施: Alcohol Brief Intervention (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Through recruitment completion, about 12 months
Number of participants divided by the number of eligible subjects
Retention rate
时间窗: 6 months after randomisation
Number of participants completed the follow-up divided by the number of participants
Weekly alcohol consumption
时间窗: 3 months after randomisation
Assessed by questions 1 and 2 of AUDIT-C
次要结局
- Frequency of heavy drinking in the past 30 days(3 months after randomisation)
- Frequency of heavy drinking in the past 30 days(6 months after randomisation)
- Frequency of binge drinking in the past 30 days(6 months after randomisation)
- Eligibility rate(Through recruitment completion, about 12 months)
- Weekly alcohol consumption(6 months after randomisation)
- Frequency of binge drinking in the past 30 days(3 months after randomisation)
- AUDIT score and level(3 months after randomisation)
- AUDIT score and level(6 months after randomisation)
- Planned drinking in the coming 30 days(3 months after randomisation)
- Planned drinking in the coming 30 days(6 months after randomisation)
研究者
Prof. Wang Man-Ping
Professor
The University of Hong Kong