Development and Clinical Evaluation of AlcoChange: a Digital Therapeutic for Patients with Alcohol-Related Liver Disease

Background and aims Maintenance of abstinence in alcohol-related liver disease (ARLD) is a major unmet therapeutic need. Digital therapeutics can deliver ongoing behavioural therapy, in real-time, for chronic conditions. The aim of this project was to develop and clinically test AlcoChange, a novel digital therapeutic for ARLD. Methods AlcoChange was developed using validated behaviour change techniques (BCTs) and a digital alcohol breathalyser. This was an open-label, single-centre study. Patients with ARLD, ongoing alcohol use (within 1 month) and possession of a suitable smartphone were eligible. Patients were recruited from inpatient and outpatient settings, and received AlcoChange therapy for 3-months. The primary outcome was reduction in alcohol use from baseline to 3-months, measured by timeline follow-back (TLFB). Secondary outcomes included: (i) compliance with the AlcoChange app, (ii) alcohol-related and all-cause hospital re-admissions up to 1-year, (iii) qualitative analysis to determine factors associated with compliance. Results Sixty-five patients were recruited, of whom forty-one completed the study per-protocol. Patients compliant with the intervention (>60 logins over 3-months) had a significant reduction in alcohol use from baseline compared to non-compliant patients [median (IQR): −100% (100% to −55.1%) vs −57.1% (−95.3% to +32.13%), p=0.029]. The proportion attaining abstinence at 3-months was higher in the compliant group (57.1% vs 22.2%, p=0.025). The compliant group had a significantly decreased risk of subsequent alcohol-related re-admission up to 12-months (p=0.008). Qualitative analysis demonstrated receiving in-app feedback and presence of health-related ‘sentinel event’ were predictors of compliance with the intervention. Conclusions Use of the novel digital therapeutic, AlcoChange, was associated with a significant reduction in alcohol use and increase in proportion attaining abstinence in ARLD patients. Definitive, randomized trials are warranted for this intervention.