A Pilot Study of Remote Home Monitoring in Patients With Advanced Cirrhosis, During COVID-19, Using Wearable Technology and an App Based Interface, to Diagnose Early and Severe Cirrhosis Decompensation, and Inform Design of a Future Randomized Controlled Intervention Study.

The current Covid Pandemic has necessitated an unusual allocation of healthcare resources which inevitably negatively impacts on resources available to care for patients with chronic diseases including liver disease. This is most marked in those with acute 'decompensation' of cirrhosis, namely the significant subset of patients who develop a rapid decline in liver function and numerous complications including, fluid overload, confusion (encephalopathy), kidney dysfunction and gastrointestinal bleeding.[Jalan et al, J Hepatol 2015; Moreau R et al, Gastroenterology 2013] These patients normally require a regular clinical assessment (every 1-2 weeks) and even when discharged following a recent admission to hospital, have re-admission rates approaching 40% in 8 weeks.[Moranda et al, J Hepatol, 2013] The current unmet need is to institute regular contact with the patient, to avoid further new complications from cirrhosis developing and hospital admission, whilst also avoiding nosocomial (health care setting related) infection with Covid 19 through standard outpatient, scheduled contact. [Tapper EB et al, J Hepatol 2020]

We propose to provide a remote management system for cirrhosis care, which will include remote acquisition of important vital signs such as heart rate, heart rate variability, blood pressure, physical activity and sleep status (through wearable technology), weight, and assessment of higher mental function (smartphone app based tools), all of which are key metrics that are perturbed as cirrhosis decompensation ensues. By efficiently collating this data and linking this to an effective clinical workflow stream based on a platform created for smartphone and clinical user application interfaces, will facilitate improved telemedicine 'consultations' by healthcare providers. This is a novel approach that in this patient cohort, which will allow early detection of signs of complications and rapid triaging of patients who need early direct clinical review, at a time when this is a limited resource. Our solution will help prioritize care whilst limiting risk of COVID-19 infection exposure, and also personalizing this to an individual patient's needs and disease, making this more acceptable and convenient for patients. In the longer term, costs savings will arise through more efficient and streamlined outpatient direct contacts, whilst all patients will receive the priority and regular care input they need.

This is a single centre study at the Royal Free London trust. This is a tertiary liver unit with significant experience in running clinical trials in decompensated cirrhosis. This pilot study has already recruited 20 cirrhosis patients with a known history of decompensation and 20 contemporaneous controls. Potential participants were identified by the PI and/or clinical fellows on the study log, using existing clinic lists and inpatient and discharge lists. The individuals have been monitored using a wrist-watch wearable device, with associated smart weighing scales and blood pressure cuff, along with a smartphone application (including economic smartphone in those patients if not available), to facilitate home monitoring. Currently an interim analysis is being performed on the data collected to assess safety and engagement.

Routine laboratory data was collected in the previous 7 days as part of standard clinical assessment prior to recruitment. Data included liver and kidney function tests and full blood count. The data is logged within the patient historical data on the Cirrhocare App.

All study specific procedures that the participant has undertaken at home were relayed in person during a first study visit meeting, to ensure all the equipment was functional, had been sync'd to work appropriately, and that the participant could operate both the wearables and the Cirrhocare App. The Investigator also provided the participant (and any carer) with written instructions but also a recorded User Guide video on the App. Following patient consent, App set-up, and Cirrhocare Healthkit sync to the patient's (or study provided) phone, and the subsequent patient education steps, the participant, under supervision, performed the baseline App based tests detailed below.