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Clinical Trials/NCT06587568
NCT06587568
Active, not recruiting
Not Applicable

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

The University of Hong Kong1 site in 1 country106 target enrollmentOctober 2, 2024
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ConditionsChronic Liver Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Liver Disease
Sponsor
The University of Hong Kong
Enrollment
106
Locations
1
Primary Endpoint
Recruitment rate
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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. 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
Registry
clinicaltrials.gov
Start Date
October 2, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tzu Tsun Luk

Research Assistant Professor

The University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Recruitment rate

Time Frame: Through recruitment completion, about 8 months

Number of participants divided by the number of eligible subjects

Retention rate

Time Frame: 6 months after randomisation

Number of participants completed the follow-up divided by the number of participants

Weekly alcohol consumption

Time Frame: 6 months after randomisation

Assessed by questions 1 and 2 of AUDIT-C

Secondary Outcomes

  • Eligibility rate(Through recruitment completion, about 8 months)
  • Weekly alcohol consumption(3 months after randomisation)
  • Frequency of heavy episodic drinking(6 months after randomisation)
  • AUDIT score and level(6 months after randomisation)
  • Total alcohol consumption in the past week(6 months after randomisation)
  • Past 7-day total alcohol consumption(3 months after randomisation)
  • Past 7-day alcohol abstinence(6 months after randomisation)
  • Past 30-day alcohol abstinence(6 months after randomisation)

Study Sites (1)

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