Mobile Chat Messaging Plus Screening-based Brief Alcohol Intervention for Patients With Chronic Liver Diseases: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Brief intervention
Screening-based alcohol intervention only
干预措施: Screening, brief intervention and referral to treatment (Behavioral)
Mobile chat messaging
Mobile chat messaging + Screening-based alcohol intervention
干预措施: Mobile chat messaging (Behavioral)
Mobile chat messaging
Mobile chat messaging + Screening-based alcohol intervention
干预措施: Screening, brief intervention and referral to treatment (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: Through recruitment completion, about 8 months
Number of participants divided by the number of eligible subjects
Retention rate
时间窗: 6 months after randomisation
Number of participants completed the follow-up divided by the number of participants
Weekly alcohol consumption
时间窗: 6 months after randomisation
Assessed by questions 1 and 2 of AUDIT-C
次要结局
- 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)
- Frequency of heavy episodic drinking(3 months after randomisation)
- AUDIT score and level(3 months after randomisation)
- Past 7-day alcohol abstinence(3 months after randomisation)
- Past 30-day alcohol abstinence(3 months after randomisation)
研究者
Tzu Tsun Luk
Research Assistant Professor
The University of Hong Kong