AlcoChange: An Open Label Pilot Study of Smartphone Monitoring for Alcoholic Liver Disease
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Details and patient eligibility
About
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).
Enrollment
Sex
Volunteers
Inclusion criteria
- presence of ARLD
- age 18-70
- intent to maintain abstinence
- possession of compatible smartphone
Exclusion criteria
- inability to provide consent.
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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