AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Self-reported alcohol consumption (average/week)
研究概览
简要总结
Alcohol contributes to over 5% of deaths worldwide, and death rates from alcohol-related liver disease (ARLD) in the UK continue to rise sharply. On-going alcohol use in ARLD leads to markedly increased mortality (Thursz et al, 2015), and maintaining abstinence is a key therapeutic goal. However, there are no effective pharmacological therapies for maintaining abstinence. Brief intervention (BI) is an effective psychological tool for reducing alcohol use, but is difficult to scale widely.
AlcoChange is a smartphone app and breathalyser (AlcoChange), which facilitates self-monitoring and delivers BIs in response to patient triggers. The aim of this open-label study is provide AlcoChange to 60 patients with ARLD, to determine compliance with the app/breathalyser and changes in self-reported alcohol consumption.
Recruitment of inpatients/outpatients with ARLD and recent alcohol use will take place at Royal Free London. The inclusion criteria are: intent to maintain abstinence, possession of compatible smartphone. The exclusion criteria are: inability to provide consent. Participants will be assessed at baseline and 3-months. The primary endpoint is self-reported alcohol use (units/week, timeline follow-back). Secondary endpoint is compliance with the app (monitored remotely).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •presence of ARLD
- •age 18-70
- •intent to maintain abstinence
- •possession of compatible smartphone
排除标准
- •inability to provide consent.
研究组 & 干预措施
Treatment arm
干预措施: AlcoChange (Device)
结局指标
主要结局
Self-reported alcohol consumption (average/week)
时间窗: 3-month study period
Assessed by time line follow back method over study period
次要结局
- Compliance with the app (no. of logins, duration spent on the app)(3-month study period)
研究者
Gautam Mehta
Honorary Consultant and Senior Lecturer in Hepatology
Royal Free Hospital NHS Foundation Trust
