- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06587568
Mobil chatbeskeder for reduktion af alkohol hos patienter med kroniske leversygdomme
Mobile Chat Messaging Plus Screening-baseret kort alkoholintervention til patienter med kroniske leversygdomme: et pilot randomiseret kontrolleret forsøg
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Hong Kong, Hong Kong
- Queen Mary Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Mobile chat messaging
Mobile chat messaging + Screening-based alcohol intervention |
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. Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet
Andre navne:
|
|
Aktiv komparator: Brief intervention
Screening-based alcohol intervention only |
Brief counselling (5 to 10 mins) to reduce drinking and a self-help booklet
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment rate
Tidsramme: Through recruitment completion, about 8 months
|
Number of participants divided by the number of eligible subjects |
Through recruitment completion, about 8 months
|
|
Retention rate
Tidsramme: 6 months after randomisation
|
Number of participants completed the follow-up divided by the number of participants |
6 months after randomisation
|
|
Weekly alcohol consumption
Tidsramme: 6 months after randomisation
|
Assessed by questions 1 and 2 of AUDIT-C |
6 months after randomisation
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Samlet alkoholforbrug i den seneste uge
Tidsramme: 6 måneder efter randomisering
|
6 måneder efter randomisering
|
|
|
Eligibility rate
Tidsramme: Through recruitment completion, about 8 months
|
Number of eligible patients divided by the number of patients screened |
Through recruitment completion, about 8 months
|
|
Weekly alcohol consumption
Tidsramme: 3 months after randomisation
|
Assessed by questions 1 and 2 of AUDIT-C |
3 months after randomisation
|
|
Frequency of heavy episodic drinking
Tidsramme: 3 months after randomisation
|
Self-reported |
3 months after randomisation
|
|
Frequency of heavy episodic drinking
Tidsramme: 6 months after randomisation
|
Assessed by question three of AUDIT-C |
6 months after randomisation
|
|
AUDIT score and level
Tidsramme: 3 months after randomisation
|
Assessed by the Alcohol Use Disorders Identification Test |
3 months after randomisation
|
|
AUDIT score and level
Tidsramme: 6 months after randomisation
|
Assessed by the Alcohol Use Disorders Identification Test |
6 months after randomisation
|
|
Past 7-day alcohol abstinence
Tidsramme: 3 months after randomisation
|
Self-reported |
3 months after randomisation
|
|
Past 7-day alcohol abstinence
Tidsramme: 6 months after randomisation
|
Self-reported |
6 months after randomisation
|
|
Past 30-day alcohol abstinence
Tidsramme: 3 months after randomisation
|
Self-reported |
3 months after randomisation
|
|
Past 30-day alcohol abstinence
Tidsramme: 6 months after randomisation
|
Self-reported |
6 months after randomisation
|
|
Past 7-day total alcohol consumption
Tidsramme: 3 months after randomisation
|
Measured in grams |
3 months after randomisation
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tzu Tsun Luk, PhD, RN, The University of Hong Kong
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Patologiske tilstande, tegn og symptomer
- Hepatitis
- Fibrose
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Diagnostiske teknikker og procedurer
- Diagnose
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Forebyggende sundhedsydelser
- Psykoterapi
- Adfærdsdiscipliner og aktiviteter
- Diagnostiske tjenester
- Sundhedsundersøgelser
- Undersøgelser og spørgeskemaer
- Public Health Practice
- Massescreening
- Kriseintervention
Andre undersøgelses-id-numre
- 21222731
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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