Clinical trial NCT06587568: Mobile Chat Messaging for Alcohol Reduction in Patients With Chronic Liver Diseases
Official title: Mobile Chat Messaging Plus Screening-based Brief Alcohol Intervention for Patients With Chronic Liver Diseases: a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Liver Disease
Keywords: drinking
cirrhosis
hepatitis
SBIRT
WhatsApp
Chinese
mHealth
ABI
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2024-09-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Through recruitment completion, about 8 months
measure: Retention rate
timeFrame: 6 months after randomisation
measure: Weekly alcohol consumption
timeFrame: 6 months after randomisation
Secondary outcomes:
measure: Eligibility rate
timeFrame: Through recruitment completion, about 8 months
measure: Weekly alcohol consumption
timeFrame: 3 months after randomisation
measure: Frequency of heavy episodic drinking
timeFrame: 3 months after randomisation
measure: Frequency of heavy episodic drinking
timeFrame: 6 months after randomisation
measure: AUDIT score and level
timeFrame: 3 months after randomisation
measure: AUDIT score and level
timeFrame: 6 months after randomisation
measure: Total alcohol consumption in the past week
timeFrame: 6 months after randomisation
measure: Past 7-day alcohol abstinence
timeFrame: 3 months after randomisation
measure: Past 7-day alcohol abstinence
timeFrame: 6 months after randomisation
measure: Past 30-day alcohol abstinence
timeFrame: 3 months after randomisation
measure: Past 30-day alcohol abstinence
timeFrame: 6 months after randomisation
measure: Past 7-day total alcohol consumption
timeFrame: 3 months after randomisation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Tzu Tsun Luk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: