Mobile Chat Messaging for Alcohol Reduction in Patients With Chronic Liver Diseases

NCT06587568 | Active Not Recruiting

• 1 other identifier: 21222731
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot randomized controlled trial is to evaluate the trial feasibility and acceptability of mobile chat messaging for reducing alcohol use among patients with chronic liver diseases. Specific objectives include:

1. 1.To assess whether the eligibility criteria were too restrictive by estimating the eligibility rate
2. 2.To assess how many eligible CLD patients accepted the invitation to participate in the trial
3. 3.To assess the participant retention rate through 6 months after treatment initiation
4. 4.To assess the intervention acceptability in terms of participants' engagement with and rating of the chat messaging intervention.
5. 5.To assess the safety of the intervention
6. 6.To estimate the intervention effect on alcohol use outcomes and liver functions
7. 7.To synthesise data to inform the sample size calculation in the future definitive trial
8. 8.To explore the participants' perception and experiences in the chat-based intervention

Conditions

Chronic Liver Disease

Keywords

drinking; cirrhosis; hepatitis; SBIRT; WhatsApp; Chinese; mHealth; ABI

Outcome Measures

Primary Outcomes (3)

• Recruitment rate

  Number of participants divided by the number of eligible subjects

  Through recruitment completion, about 8 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

  6 months after randomisation

Secondary Outcomes (12)

• Eligibility rate

  Through recruitment completion, about 8 months

• Weekly alcohol consumption

  3 months after randomisation

• Frequency of heavy episodic drinking

  3 months after randomisation

• Frequency of heavy episodic drinking

  6 months after randomisation

• AUDIT score and level

  3 months after randomisation

Study Arms (2)

Mobile chat messaging

EXPERIMENTAL

Mobile chat messaging + Screening-based alcohol intervention

Behavioral: Mobile chat messaging; Behavioral: Screening, brief intervention and referral to treatment

Brief intervention

ACTIVE COMPARATOR

Screening-based alcohol intervention only

Behavioral: Screening, brief intervention and referral to treatment

Interventions

Mobile chat messaging BEHAVIORAL

A trained counsellor will interact with a participant individually and provide personalised alcohol reduction information and advice via a mobile instant messaging app in real time for 3 months from randomisation.

Mobile chat messaging

Screening, brief intervention and referral to treatment BEHAVIORAL

Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet

Also known as: SBIRT

Brief intervention; Mobile chat messaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Diagnosed with chronic liver disease
• Alcohol Use Disorders Identification Test score ≥8
• Own a smartphone with a mobile instant messaging app installed
• Able to read and communicate in Chinese

You may not qualify if:

• Having a psychiatric or psychological disease or on psychotropic drugs
• Participating in other alcohol reduction or abstinence programmes
• Require emergency or in-patient treatment after consultation

Sponsors & Collaborators

• The University of Hong Kong: lead
• Health and Medical Research Fund: collaborator

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Fibrosis; Hepatitis

Interventions

Mass Screening; Crisis Intervention

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tzu Tsun Luk, PhD, RN

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: October 2, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

HK (1)