Chronic Liver DiseaseNCT06587568
Mobile Chat Messaging for Alcohol Reduction in Patients With Chronic Liver Diseases
A study testing Mobile chat messaging and Screening, brief intervention and referral to treatment in people with Chronic Liver Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Mobile chat messaging and Screening, brief intervention and referral to treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
- To assess whether the eligibility criteria were too restrictive by estimating the eligibility rate
- To assess how many eligible CLD patients accepted the invitation to participate in the trial
- To assess the participant retention rate through 6 months after treatment initiation
- To assess the intervention acceptability in terms of participants' engagement with and rating of the chat messaging intervention.
- To assess the safety of the intervention
- To estimate the intervention effect on alcohol use outcomes and liver functions
- To synthesise data to inform the sample size calculation in the future definitive trial
- To explore the participants' perception and experiences in the chat-based intervention
- Conditions
- Chronic Liver Disease
- Being tested
- Mobile chat messaging, Screening, brief intervention and referral to treatment
- Keywords
- drinking, cirrhosis, hepatitis, SBIRT, WhatsApp, Chinese, mHealth, ABI
- Medical subject headings
- Fibrosis, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile chat messagingBehavioural
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.
Screening, brief intervention and referral to treatmentBehavioural
Also called SBIRT
Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet
| Study group | Role | What they receive |
|---|---|---|
| Mobile chat messaging | Experimental | Mobile chat messaging + Screening-based alcohol intervention Receives: Behavioral: Mobile chat messaging; Behavioral: Screening, brief intervention and referral to treatment |
| Brief intervention | Active comparator | Screening-based alcohol intervention only Receives: Behavioral: Screening, brief intervention and referral to treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants divided by the number of eligible subjects
Measured: Through recruitment completion, about 8 months
Retention rate
Number of participants completed the follow-up divided by the number of participants
Measured: 6 months after randomisation
Weekly alcohol consumption
Assessed by questions 1 and 2 of AUDIT-C
Measured: 6 months after randomisation
Secondary outcomes (12)
Eligibility rate
Number of eligible patients divided by the number of patients screened
Measured: Through recruitment completion, about 8 months
Weekly alcohol consumption
Assessed by questions 1 and 2 of AUDIT-C
Measured: 3 months after randomisation
Frequency of heavy episodic drinking
Self-reported
Measured: 3 months after randomisation
Frequency of heavy episodic drinking
Assessed by question three of AUDIT-C
Measured: 6 months after randomisation
AUDIT score and level
Assessed by the Alcohol Use Disorders Identification Test
Measured: 3 months after randomisation
AUDIT score and level
Assessed by the Alcohol Use Disorders Identification Test
Measured: 6 months after randomisation
Total alcohol consumption in the past week
Measured: 6 months after randomisation
Past 7-day alcohol abstinence
Self-reported
Measured: 3 months after randomisation
Past 7-day alcohol abstinence
Self-reported
Measured: 6 months after randomisation
Past 30-day alcohol abstinence
Self-reported
Measured: 3 months after randomisation
Past 30-day alcohol abstinence
Self-reported
Measured: 6 months after randomisation
Past 7-day total alcohol consumption
Measured in grams
Measured: 3 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Oct 2024
- Primary completion19 Sep 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health and Medical Research Fund
- Responsible party
- Principal investigator, Tzu Tsun Luk, The University of Hong Kong
- Investigators
- Tzu Tsun Luk, PhD, RN, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587568
- Sponsor's protocol ID
- 21222731
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Chat Messaging Plus Screening-based Brief Alcohol Intervention for Patients With Chronic Liver Diseases: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06587568
- Acronym / sponsor ID
- 21222731
- Conditions
- Chronic Liver Disease
- Keywords
- drinking, cirrhosis, hepatitis, SBIRT, WhatsApp, Chinese, mHealth, ABI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health and Medical Research Fund
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To assess whether the eligibility criteria were too restrictive by estimating the eligibility rate
- To assess how many eligible CLD patients accepted the invitation to participate in the trial
- To assess the participant retention rate through 6 months after treatment initiation
- To assess the intervention acceptability in terms of participants' engagement with and rating of the chat messaging intervention.
- To assess the safety of the intervention
- To estimate the intervention effect on alcohol use outcomes and liver functions
- To synthesise data to inform the sample size calculation in the future definitive trial
- To explore the participants' perception and experiences in the chat-based intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile chat messaging | Experimental | Behavioral: Mobile chat messaging, Behavioral: Screening, brief intervention and referral to treatmentMobile chat messaging + Screening-based alcohol intervention |
| Brief intervention | Active comparator | Behavioral: Screening, brief intervention and referral to treatmentScreening-based alcohol intervention only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile chat messagingA 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. | Behavioural | Mobile chat messaging |
| Screening, brief intervention and referral to treatmentAlso: SBIRTBrief counselling (5 to 10 mins) to reduce drinking and a self-help booklet | Behavioural | Brief intervention, Mobile chat messaging |
Primary outcome
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
12 secondary outcomes
Eligibility rate
Time frame: Through recruitment completion, about 8 months
Weekly alcohol consumption
Time frame: 3 months after randomisation
Frequency of heavy episodic drinking
Time frame: 3 months after randomisation
Frequency of heavy episodic drinking
Time frame: 6 months after randomisation
AUDIT score and level
Time frame: 3 months after randomisation
AUDIT score and level
Time frame: 6 months after randomisation
Total alcohol consumption in the past week
Time frame: 6 months after randomisation
Past 7-day alcohol abstinence
Time frame: 3 months after randomisation
Past 7-day alcohol abstinence
Time frame: 6 months after randomisation
Past 30-day alcohol abstinence
Time frame: 3 months after randomisation
Past 30-day alcohol abstinence
Time frame: 6 months after randomisation
Past 7-day total alcohol consumption
Time frame: 3 months after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Liver Disease
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingPhase 2
A Study of HT-101 and HT-102 in Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection
RecruitingPhase 2
A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD)
Liver Diseases, Alcoholic
RecruitingObservational study
Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
Hepatitis D
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tzu Tsun Luk, PhD, RN principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile chat messaging and Screening, brief intervention and referral to treatment in people with Chronic Liver Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Through recruitment completion, about 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.