Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
Study NCT ID:
NCT06587568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-01
First Post:
2024-09-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobile Chat Messaging for Alcohol Reduction in Patients With Chronic Liver Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D006505', 'term': 'Hepatitis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008403', 'term': 'Mass Screening'}, {'id': 'D003419', 'term': 'Crisis Intervention'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006306', 'term': 'Health Surveys'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate', 'timeFrame': 'Through recruitment completion, about 8 months', 'description': 'Number of participants divided by the number of eligible subjects'}, {'measure': 'Retention rate', 'timeFrame': '6 months after randomisation', 'description': 'Number of participants completed the follow-up divided by the number of participants'}, {'measure': 'Weekly alcohol consumption', 'timeFrame': '6 months after randomisation', 'description': 'Assessed by questions 1 and 2 of AUDIT-C'}], 'secondaryOutcomes': [{'measure': 'Eligibility rate', 'timeFrame': 'Through recruitment completion, about 8 months', 'description': 'Number of eligible patients divided by the number of patients screened'}, {'measure': 'Weekly alcohol consumption', 'timeFrame': '3 months after randomisation', 'description': 'Assessed by questions 1 and 2 of AUDIT-C'}, {'measure': 'Frequency of heavy episodic drinking', 'timeFrame': '3 months after randomisation', 'description': 'Self-reported'}, {'measure': 'Frequency of heavy episodic drinking', 'timeFrame': '6 months after randomisation', 'description': 'Assessed by question three of AUDIT-C'}, {'measure': 'AUDIT score and level', 'timeFrame': '3 months after randomisation', 'description': 'Assessed by the Alcohol Use Disorders Identification Test'}, {'measure': 'AUDIT score and level', 'timeFrame': '6 months after randomisation', 'description': 'Assessed by the Alcohol Use Disorders Identification Test'}, {'measure': 'Total alcohol consumption in the past week', 'timeFrame': '6 months after randomisation'}, {'measure': 'Past 7-day alcohol abstinence', 'timeFrame': '3 months after randomisation', 'description': 'Self-reported'}, {'measure': 'Past 7-day alcohol abstinence', 'timeFrame': '6 months after randomisation', 'description': 'Self-reported'}, {'measure': 'Past 30-day alcohol abstinence', 'timeFrame': '3 months after randomisation', 'description': 'Self-reported'}, {'measure': 'Past 30-day alcohol abstinence', 'timeFrame': '6 months after randomisation', 'description': 'Self-reported'}, {'measure': 'Past 7-day total alcohol consumption', 'timeFrame': '3 months after randomisation', 'description': 'Measured in grams'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['drinking', 'cirrhosis', 'hepatitis', 'SBIRT', 'WhatsApp', 'Chinese', 'mHealth', 'ABI'], 'conditions': ['Chronic Liver Disease']}, 'descriptionModule': {'briefSummary': "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:\n\n1. To assess whether the eligibility criteria were too restrictive by estimating the eligibility rate\n2. To assess how many eligible CLD patients accepted the invitation to participate in the trial\n3. To assess the participant retention rate through 6 months after treatment initiation\n4. To assess the intervention acceptability in terms of participants' engagement with and rating of the chat messaging intervention.\n5. To assess the safety of the intervention\n6. To estimate the intervention effect on alcohol use outcomes and liver functions\n7. To synthesise data to inform the sample size calculation in the future definitive trial\n8. To explore the participants' perception and experiences in the chat-based intervention"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. Diagnosed with chronic liver disease\n3. Alcohol Use Disorders Identification Test score ≥8\n4. Own a smartphone with a mobile instant messaging app installed\n5. Able to read and communicate in Chinese\n\nExclusion Criteria:\n\n1. Having a psychiatric or psychological disease or on psychotropic drugs\n2. Participating in other alcohol reduction or abstinence programmes\n3. Require emergency or in-patient treatment after consultation'}, 'identificationModule': {'nctId': 'NCT06587568', 'briefTitle': 'Mobile Chat Messaging for Alcohol Reduction in Patients With Chronic Liver Diseases', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Mobile Chat Messaging Plus Screening-based Brief Alcohol Intervention for Patients With Chronic Liver Diseases: a Pilot Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '21222731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile chat messaging', 'description': 'Mobile chat messaging + Screening-based alcohol intervention', 'interventionNames': ['Behavioral: Mobile chat messaging', 'Behavioral: Screening, brief intervention and referral to treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brief intervention', 'description': 'Screening-based alcohol intervention only', 'interventionNames': ['Behavioral: Screening, brief intervention and referral to treatment']}], 'interventions': [{'name': 'Mobile chat messaging', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Mobile chat messaging']}, {'name': 'Screening, brief intervention and referral to treatment', 'type': 'BEHAVIORAL', 'otherNames': ['SBIRT'], 'description': 'Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet', 'armGroupLabels': ['Brief intervention', 'Mobile chat messaging']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Tzu Tsun Luk, PhD, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health and Medical Research Fund', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Tzu Tsun Luk', 'investigatorAffiliation': 'The University of Hong Kong'}}}}