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临床试验/NCT03474328
NCT03474328Unknown不适用

AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease

Royal Free Hospital NHS Foundation Trust0 个研究点目标入组 60 人开始时间: 2016年4月25日最近更新:
适应症
干预措施

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

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

Experimental

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

发起方
Royal Free Hospital NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gautam Mehta

Honorary Consultant and Senior Lecturer in Hepatology

Royal Free Hospital NHS Foundation Trust

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