AlcoChange: A digital therapeutic for patients with alcohol-related liver disease

Abstract

Background and aimsMaintenance 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.MethodsAlcoChange 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.ResultsSixty-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.ConclusionsUse 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.Impact and implicationsAlcohol-related liver disease (ARLD) is an increasing health problem worldwide. The main cause of death and disability in ARLD is ongoing alcohol consumption, but few patients receive medications or talking therapy to maintain abstinence. This study demonstrated that a digital therapeutic, linked to a smartphone, may help reduce alcohol consumption and alcohol-related hospital admissions in these patients. If validated in larger, randomized, trials, digital therapeutics may have a role in the primary and secondary prevention of complicatons from ARLD.