A smartphone app called AlcoChange is being tested in a large trial across 18 UK hospitals to see if it can help patients with alcohol-related liver disease cut down their drinking. Liver disease is now the second most common cause of preventable death in the UK, and 80% of cases are driven by excess alcohol. For patients already diagnosed with alcohol-related liver disease, continuing to drink sharply increases their risk of severe illness and death. Yet standard hospital care often fails to help these patients change their behaviour long-term. AlcoChange is a digital therapeutic—a treatment delivered through a phone app—that showed promise in a smaller pilot study by reducing alcohol use among hospitalised patients. If this stepped-wedge randomised trial of 324 patients confirms that AlcoChange works, the app could become a low-cost, scalable tool embedded into routine NHS care. That would give clinicians a practical way to support patients after discharge, potentially slowing disease progression, reducing hospital readmissions, and saving the health system money. The study will also assess cost-effectiveness and identify barriers to rolling the app out across the NHS, laying the groundwork for commercialisation if the results are positive.
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Research question: What is the efficacy of AlcoChange, in addition to usual care for reducing alcohol use in patients with alcohol-related liver disease (ARLD), compared with usual care alone? Background: Liver disease is now the second most common cause of preventable death in the UK. This is primarily (80%) due to excess alcohol use. Ongoing alcohol use is a key predictor of morbidity and mortality in ARLD. However, widespread failings in the management of ARLD in the acute setting have been documented. AlcoChange is a digital therapeutic (DTx), which has demonstrated reductions in alcohol use amongst hospitalised ARLD patients in a pilot study. Aims and Objectives: Primary Objective: Evaluate the efficacy of AlcoChange to reduce alcohol use in ARLD patients. Secondary Objectives: Define the cost-effectiveness of secondary care implementation of AlcoChange. Understand barriers to implementation of AlcoChange into clinical practice. Measure the effects of AlcoChange on health-related quality of life. ? Prepare the business development strategy, if the primary endpoint is met, for AlcoChange to be commercialised and implemented. Methods: A stepped-wedge randomised controlled trial (RCT) will be conducted in 6 clusters (18 centres). Patients with ARLD and ongoing alcohol use (n=324) will be recruited over 18 months. The primary endpoint will be self-reported alcohol use at 180 days. Timelines: Set up of the data platform, the RCT, and qualitative work to inform the toolkit for delivery of the intervention, will take place from month 0-6. The RCT will start recruiting in month 7. Recruitment will continue for 18 months, with final patient data being delivered in month 31. Data cleaning, analysis, interpretation, dissemination and commercialisation plan will take place in month 31-36. Impact and Dissemination: The work will be disseminated through academic journals, and targeted discussion with patients, clinicians, commissioners, and guidance producers such as NICE.
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