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


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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2018


  • Device: AlcoChange
    • Smartphone app and breathalyser

Arms, Groups and Cohorts

  • Experimental: Treatment arm

Clinical Trial Outcome Measures

Primary Measures

  • Self-reported alcohol consumption (average/week)
    • Time Frame: 3-month study period
    • Assessed by time line follow back method over study period

Secondary Measures

  • Compliance with the app (no. of logins, duration spent on the app)
    • Time Frame: 3-month study period
    • This will be assessed independently, and for associations of compliance with the app and changes in alcohol consumption (primary endpoint)

Participating in This Clinical Trial

Inclusion Criteria

  • presence of ARLD – age 18-70 – intent to maintain abstinence – possession of compatible smartphone Exclusion Criteria:

  • inability to provide consent.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Royal Free Hospital NHS Foundation Trust
  • Provider of Information About this Clinical Study
    • Principal Investigator: Gautam Mehta, Honorary Consultant and Senior Lecturer in Hepatology – Royal Free Hospital NHS Foundation Trust

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