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

Mobile Chat Messaging Plus Screening-based Brief Alcohol Intervention for Patients With Chronic Liver Diseases: a Pilot Randomised Controlled Trial

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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Liver Disease
• Intervention / Treatment: Behavioral: Mobile chat messaging; Behavioral: Screening, brief intervention and referral to treatment

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile chat messaging; Mobile chat messaging + Screening-based alcohol intervention	Behavioral: Mobile chat messaging; 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.; Behavioral: Screening, brief intervention and referral to treatment; Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet; Other Names: SBIRT
Active Comparator: Brief intervention; Screening-based alcohol intervention only	Behavioral: Screening, brief intervention and referral to treatment; Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet; Other Names: SBIRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eligibility rate	Number of eligible patients divided by the number of patients screened	Through recruitment completion, about 8 months
Weekly alcohol consumption	Assessed by questions 1 and 2 of AUDIT-C	3 months after randomisation
Frequency of heavy episodic drinking	Self-reported	3 months after randomisation
Frequency of heavy episodic drinking	Assessed by question three of AUDIT-C	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
Total alcohol consumption in the past week		6 months after randomisation
Past 7-day alcohol abstinence	Self-reported	3 months after randomisation
Past 7-day alcohol abstinence	Self-reported	6 months after randomisation
Past 30-day alcohol abstinence	Self-reported	3 months after randomisation
Past 30-day alcohol abstinence	Self-reported	6 months after randomisation
Past 7-day total alcohol consumption	Measured in grams	3 months after randomisation

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Health and Medical Research Fund
• Investigators: Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 5, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Chinese; drinking; mHealth; cirrhosis; SBIRT; WhatsApp; ABI; hepatitis
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 21222731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No