CirrhoCare - using smart-phone technology to enhance care and access to treatment for cirrhosis

INTERVENTION: Trial Design and methodology of the randomised controlled trial: 1. Phase IIb 2. Open‐label: participants and physicians treating the patient will be informed of their randomisation arm. However, an adjudication committee will assess all decompensation events by a group of clinicians not aware of the intervention allocation. Health Condition(s) or Problem(s) Studied: Advanced liver cirrhosis patients who have been hospitalised for decompensation. Target Sample Size: 214 Intervention and Control Arms: Intervention: 107 patients randomised to receive the CirrhoCare management system. Control: 107 patients randomised to receive the standard of care. Participants will be randomised into one of two groups: Intervention (CirrhoCare management system) or Control (standard of care). Each participant will have an equal chance of being assigned to either of the groups. Participants and their physicians will not be blinded to study arm allocation, which means they will know the group they are randomised to. Trial Setting: The trial will recruit 214 patients from at least 12 sites across the UK. The aim is to recruit patients with advanced liver cirrhosis who have been hospitalised for decompensation. The recruitment period is 1 year. Visits and assessments: Pre‐screening/randomisation visit (72 hours prior to discharge) All potential participants will be properly informed and made aware of the trial objectives and activities. Each participant will be made aware that they have an equal chance of being allocated to the CirrhoCare Manageme CONDITION: Complications of cirrhosis ; Digestive System PRIMARY OUTCOME: To investigate whether the CirrhoCare management system leads to a reduction in the requirement for hospital intervention from new‐liver‐related complications (ascites, overt hepatic encephalopathy, infection or portal hypertensive bleeding and renal impairment) over 12 weeks from randomisation. This will be measured by collecting the data on hospital interventions of patients, (predominantly readmissions) on the CirrhoCare management system arm compared with the standard arm over 12 weeks from randomisation. SECONDARY OUTCOME: ; 1. Determine the effects of the CirrhoCare management system on the liver disease severity as assessed by reduction in CLIF‐C AD score, or Model for End‐stage Liver. This will be measured using the CLIF‐C AD score at baseline and follow‐up visits at 4, 8 and 12 weeks.; 2. Assess healthcare resource use and cost analysis over 12 weeks from randomisation; 3. Assessment of user experience and engagement through questionnaires and interviews; 4. Health‐related Quality of Life (EQ‐5D‐5L) and frailty assessment (Liver Frailty Index) at 12 weeks; 5. Mortality (overall survival) over 12 weeks; 6. Length of hospital stay and number of hospital readmissions over 12 weeks from randomisation; 7. Assessment of the effects of the individual components making up the primary outcome measure over 12 weeks; 8. The longitudinal effects of all secondary outcomes will be investigated by using an appropriate model that incorporates the week 4 and week 8 visits in addition to the week 12; 9. Assessment of the number of hospital readmissions for a given participant and the length of stay of each hospitalisation, over 12 weeks follow‐up; INCLUSION CRITERIA: 1. Adults > = 18 years diagnosed with cirrhosis of any aetiology. 2. 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 stable corticosteroid dose for > = 3‐month period before study inclusion. 3. Cirrhosis severity risk defined by the European‐Foundation Consortium Liver Failure ‐ Acute Decompensation score (CLIF‐C AD score) > = 45 points but < 60 points at the time of screening. 4. Hospitalisation for acute decompensation (determined as one or more of the following: increasing ascites, portal hypertensive‐related bleeding, overt hepatic encephalopathy, new infection). 5. Participants who are able to give informed consent.