The CirrhoCare trial is a multi-centre, open label randomised controlled trial in patients with decompensated cirrhosis. The trial aims to investigate the clinical and cost-effectiveness of CirrhoCare digital home monitoring and management with current standard of care in these patients.
Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for ≥3-month period before study inclusion (to be recorded on concomitant log).
Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65 points at the time of screening.
Hospitalisation for acute decompensation [determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy, spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome - acute kidney injury (HRS-AKI)].
Participants with ACLF grade 2 and above according to the criteria published by Moreau
Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.
Participants with active hepatocellular carcinoma (HCC) or history of HCC that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria.
Parallel
CirrhoCare management system
DeviceThis is a UKCA-marked, digital-therapeutic system consisting of: * clinical-grade, cirrhosis monitoring sensors and a smartphone app, * a clinical team-facing, decision-facilitating dashboard, and * CyberLiver's platform incorporating hepatic algorithms. The CirrhoCare kit consists of: - Apple watch - iPhone with an in-built CirrhoCare app - a digital Bluetooth-linked system comprised of: \~Wellue BP monitor, \~Wellue weighing scale \~Bluetooth thermometer. The CirrhoCare management system also includes: * The clinician dashboard: All participant data collected through the app will be reviewed by the clinical team via the clinician dashboard. * The CirrhoCare algorithm: This algorithm will advise the clinical team if the participant is at high, medium, or low risk of developing a particular outcome event, based on monitoring data collected each day from the participant which is compared to the baseline values and average values collected over the first week of monitoring.
Number of hospital interventions from new-liver related complications
The CirrhoCare trial will investigate whether the CirrhoCare management system leads to a reduction in the requirement for unplanned medical intervention from new-liver related complications over 90 days from hospital discharge.
Effects on CLIF-C AD score
To determine the effects of the CirrhoCare management system on the Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score. \[Minimum score is 0 and there is no upper limit. The higher the score the worse the outcome)
Effects on MELD score
To determine the effects of the CirrhoCare management system on the Model for End-Stage Liver Disease score ( MELD). \[Score ranges from 6-40. The higher the score the worse the outcome\]
To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days
To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days.
Healthcare resource use analysis
To assess healthcare resource use through analysis of the number of healthcare appointments during the study period
Nutritional impact analysis
To assess whether there is a change in nutritional status using the Royal Free Hospital Nutrition Prioritizing Tool (RFH-NPT). The score ranges from 0-7, with higher scores being associated with an increased risk of malnutrition.
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University College, London
Lead sponsor
CyberLiver Ltd
Collaborator
London School of Hygiene and Tropical Medicine
Collaborator
