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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Hong Kong, Hongkong
- Rekrutierung
- Hong Kong Queen Mary Hospital
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Kontakt:
- Man Ping Wang, Prof
- Telefonnummer: +85239176636
- E-Mail: mpwang@hku.hk
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Retention rate
Zeitfenster: 6 months after randomisation
|
Number of participants completed the follow-up divided by the number of participants |
6 months after randomisation
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Weekly alcohol consumption
Zeitfenster: 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
Zeitfenster: Through recruitment completion, about 12 months
|
Number of participants divided by the number of eligible subjects |
Through recruitment completion, about 12 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Weekly alcohol consumption
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Through recruitment completion, about 12 months
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 months after randomisation
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Self-reported |
6 months after randomisation
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SLD
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