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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLM-based chatbot | Experimental | LLM-based chatbot + Alcohol Brief Intervention |
|
| Telephone counseling | Active Comparator | Telephone counseling + Alcohol Brief Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLM-based chatbot | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Number of participants divided by the number of eligible subjects | Through recruitment completion, about 12 months |
| Retention rate | Number of participants completed the follow-up divided by the number of participants | 6 months after randomisation |
| Weekly alcohol consumption | Assessed by questions 1 and 2 of AUDIT-C | 3 months after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Eligibility rate | Number of eligible patients divided by the number of patients screened | Through recruitment completion, about 12 months |
| Weekly alcohol consumption | Assessed by questions 1 and 2 of AUDIT-C |
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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).
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
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Single (Outcomes Assessor)
|
| Telephone counseling | Behavioral | 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. |
|
| Alcohol Brief Intervention | Behavioral | Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet |
|
| 6 months after randomisation |
| Frequency of binge drinking in the past 30 days | Self-reported | 3 months after randomisation |
| Frequency of binge drinking in the past 30 days | Self-reported | 6 months after randomisation |
| Frequency of heavy drinking in the past 30 days | Self-reported | 3 months after randomisation |
| Frequency of heavy drinking in the past 30 days | Self-reported | 6 months after randomisation |
| AUDIT score and level | Assessed by the Alcohol Use Disorders Identification Test | 3 months after randomisation |
| AUDIT score and level | Assessed by the Alcohol Use Disorders Identification Test | 6 months after randomisation |
| Planned drinking in the coming 30 days | Self-reported | 3 months after randomisation |
| Planned drinking in the coming 30 days | Self-reported | 6 months after randomisation |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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