Real world implementation of AlcoChange, a smartphone digital therapeutic to improve outcomes from alcohol-related liver disease: protocol for an individually randomised parallel group controlled trial

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BACKGROUND: Deaths from alcohol-related liver disease (ARLD) are rising in the UK, representing a significant public health crisis. Effective interventions are urgently needed to reduce alcohol consumption and improve outcomes for individuals with ARLD. While behaviour change interventions (BCIs) are effective, their scalability is limited. Digital therapeutics offer a promising avenue for delivering BCIs remotely and at scale. AlcoChange, a novel digital therapeutic combining a smartphone app and digital breathalyser, delivers personalised BCIs based on patient triggers. Preliminary data suggest its potential efficacy in reducing alcohol use. METHODS: This is a multi-centre, two-arm, parallel-group, individually randomised controlled trial comparing usual care (review by a hospital Alcohol Care Team and brief intervention) with usual care plus AlcoChange in patients with ARLD. POPULATION: Adults aged 18 years or older with a diagnosis of ARLD (including cirrhosis, fibrosis, steatohepatitis, or recent alcoholic hepatitis) who have been advised to abstain from alcohol and intend to do so, and who have access to a smartphone. INTERVENTION: Usual care plus AlcoChange, comprising a smartphone app and digital breathalyser delivering personalised behaviour change techniques. COMPARISON: Usual care alone. OUTCOME: The primary outcome is the proportion of patients abstinent or reporting low-risk alcohol consumption (< 14 units/week) at 180 days post-randomisation, assessed using the Timeline Follow-Back (TLFB) method. Secondary outcomes include self-reported alcohol use at various time points, liver disease severity, health-related quality of life, healthcare resource utilisation, and cost-effectiveness. Four hundred participants will be recruited from up to 18 NHS hospitals in England and randomised 1:1. A mixed-methods approach was used to develop the trial protocol, including a theory of change framework and bespoke training materials for the TLFB assessment. DISCUSSION: This trial will evaluate the real-world efficacy and cost-effectiveness of AlcoChange in reducing alcohol consumption and alcohol-related harm in individuals with ARLD. The study addresses the urgent need for scalable interventions to combat the rising burden of ARLD in the UK. The pragmatic design and mixed methods approach to implementation aim to enhance the generalizability and impact of the findings. The trial will provide valuable evidence to inform clinical practice and policy regarding the use of digital therapeutics for alcohol use disorder and liver disease.

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