About AlcoChange Study
AlcoChange is a multicentre, 2-arm individually randomised controlled trial comparing usual care against usual care plus the AlcoChange intervention (breathalyser and app) in patients with ArLD. The treatment allocation ratio will be 1:1. Patients will be recruited from up to 18 UK hospitals over 12 months.
Deaths from liver disease are increasing at an alarming rate in the UK, primarily due to excess alcohol use – 80% of liver disease in the UK is due to alcohol. The recent Lancet Commission on liver disease highlighted significant variations in care for people with alcohol-related liver disease (ArLD). The 2013 National Confidential Enquiry into Patient Outcome and Death documented widespread failings in the detection and management of ArLD in the acute setting.
More than 1.1 million hospital admissions associated with alcohol were recorded in 2018, which was a further increase from 2017. Despite this, only 6% of harmful drinkers receive any input from alcohol services. These individuals are also heavy users of healthcare services.
Alcohol-related harm costs the NHS more than £3.5 billion each year. Morbidity and mortality associated with alcohol misuse account for more premature deaths amongst individuals of working age than cigarette smoking in the UK. Two-thirds of these deaths are due to ArLD. Ongoing alcohol use is the single most important determinant of long-term survival in ArLD. Thus, any intervention that decreases alcohol use and improves abstinence will improve mortality in this group.
The current NHS care pathway for individuals admitted with alcohol-related harm is evaluation by an alcohol care team. However, with the alarming rise in patients presenting with alcohol-related problems, there is increasing pressure on resources and access to alcohol care teams, Hence, referral times are increasing and an unmet clinical need has arisen. There are no effective pharmacological therapies to maintain abstinence amongst patients with ArLD. By contrast, behaviour change interventions (BCIs) are effective tools for reducing alcohol consumption in individuals without ArLD (Number Needed to Treat; NNT=8). However, only around 6% of individuals with harmful drinking receive a BCI, and this face-to-face intervention is difficult to scale. Smartphone applications as a digital therapeutic are an effective way to remotely deliver BCIs and are easily scalable.
Patients who take part in the study will either continue to receive their usual care only, or they will receive their usual care plus the AlcoChange app and breathalyser. Both groups will attend two study clinic visits over 6 months and will complete one telephone questionnaire with a member of the study team, as shown in the figure below.
Amanda took part in a pilot study of the #AlcoChange app and breathalyser at the Royal Free Hospital.— AlcoChange Study (@AlcoChangeStudy) December 5, 2022
The AlcoChange #ClinicalTrial @SouthamptonCTU is now testing if this digital intervention can reduce drinking and improve outcomes for people with alcohol-related liver disease. pic.twitter.com/pjOyITpiJ5
The AlcoChange device
The AlcoChange device is a novel, patented, UKCA-marked digital therapeutic based on a smartphone app and breathalyser, developed with feedback from alcohol service users and validated in a pilot study in a clinical setting in the UK.
Based on EU guidance on mobile apps and devices at the time of the pilot study (Medical Devices Directive MDD93/42/EEC, the Active Implantable Directive AIMDD90/385/EEC, and the In Vitro Diagnostics Directive IVD98/79/EC), the Medicines and Healthcare products Regulatory Agency (MHRA) approved AlcoChange as an in vitro diagnostic device, rather than a medical device. AlcoChange was registered as an in vitro diagnostic device under EU regulation IVD98/79/EC, and has a UKCA mark which is equivalent to MHRA approval. As such, the AlcoChange app and device is compliant with EU regulations.
AlcoChange for pateints with ArLD
AlcoChange allows self-monitoring of craving, alcohol use/abstinence, and breath alcohol, and provides motivational messaging in response to patient triggers. Additionally there are a number of behaviour change ‘nudges’ built into the app. Behaviour change interventions (BCIs), e.g. brief interventions, are effective tools for reducing alcohol consumption, but are difficult to scale widely and not always delivered at a time when the patient is receptive. AlcoChange delivers BCIs in real time, in response to patient triggers such as cravings or geographical location. Users of the AlcoChange device are encouraged to record cravings for alcohol, and in response to cravings, they are sent motivational messages containing pre-designed content including pictures of family or connecting to named supportive friends or the charity helpline “Drinkline”.
AlcoChange has already been shown to have positive benefits in the pilot study carried out at the Royal Free Hospital in London. Pilot data demonstrated ~60% dose-dependent reduction in alcohol use from baseline at 3 months, amongst individuals with ArLD who were compliant with AlcoChange Read more
Amanda’s story: a patient’s experience of AlcoChange
Following this pilot study, the technology is now at an appropriate stage of development for real-world clinical evaluation in a secondary care setting. Reducing admissions and mortality from ArLD is the first clinical opportunity for AlcoChange.
Following this pilot study, the technology is now at an appropriate stage of development for real-world clinical evaluation in a secondary care setting. Reducing admissions and mortality from ArLD is the first clinical opportunity for AlcoChange. Extrapolating from our pilot study, we anticipate healthcare cost savings of more than £130 million/year in England alone
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