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Recruiting NCT07450144

A Large Language Model-based Chatbot for Alcohol Reduction in Patients With Metabolic Alcohol-Related Liver Disease

No phase Interventional Metabolic Dysfunction-Associated Steatotic Liver Disease Metabolic Alcohol-Related Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LLM-based chatbot, Telephone counseling, Alcohol Brief Intervention.
Who it may be relevant to
Registry conditions: Metabolic Dysfunction-Associated Steatotic Liver Disease, Metabolic Alcohol-Related Liver Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Large Language Model-based Chatbot for Alcohol Reduction Counseling in MetALD Patients: A Pilot Randomized Controlled Trial

Overview

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

Interventions

  • Behavioral 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.
  • Behavioral 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.
  • Behavioral Alcohol Brief Intervention
    Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet

Primary outcome measures

  • Recruitment rate [Time frame: Through recruitment completion, about 12 months]
  • Retention rate [Time frame: 6 months after randomisation]
  • Weekly alcohol consumption [Time frame: 3 months after randomisation]
Secondary outcome measures (10)
  • Eligibility rate [Time frame: Through recruitment completion, about 12 months]
  • Weekly alcohol consumption [Time frame: 6 months after randomisation]
  • Frequency of binge drinking in the past 30 days [Time frame: 3 months after randomisation]
  • Frequency of binge drinking in the past 30 days [Time frame: 6 months after randomisation]
  • Frequency of heavy drinking in the past 30 days [Time frame: 3 months after randomisation]
  • Frequency of heavy drinking in the past 30 days [Time frame: 6 months after randomisation]
  • AUDIT score and level [Time frame: 3 months after randomisation]
  • AUDIT score and level [Time frame: 6 months after randomisation]
  • Planned drinking in the coming 30 days [Time frame: 3 months after randomisation]
  • Planned drinking in the coming 30 days [Time frame: 6 months after randomisation]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Diagnosed with mental disease or cognitive impairments, or
  • Participating in other ongoing clinic trials

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Hong Kong Queen Mary Hospital — Hong Kong

Identifiers

NCT: NCT07450144 · MetALD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗