ActiveDigestion, Kidneys & Other OrgansLungs & Breathing
CirrhoCare: A real-world, randomised controlled study, to determine the clinical and cost effectiveness of CirrhoCare digital home monitoring and management in patients with decompensated cirrhosis
A digital monitoring system called CirrhoCare will be tested against standard care in 214 patients with decompensated cirrhosis across 12 NHS trusts, in a randomised controlled trial. Liver disease is the third most common cause of premature death in the UK, costing the NHS over £4.53 billion annually. Most of this cost comes from complications of decompensated cirrhosis, which currently sends 114,347 patients to hospital for weeks-long stays. After discharge, standard outpatient follow-up happens at 4 weeks and then every 8–12 weeks—yet 37% of patients are readmitted within 4 weeks with new complications. The current care pathway is reactive, catching problems too late. CirrhoCare combines clinical-grade sensors, a smartphone app, and a clinician dashboard with decision-support algorithms. Patients are monitored daily at home, and the system flags complications early, enabling timely community-based interventions. If the trial succeeds in reducing liver-related complications requiring hospital intervention—from a baseline rate of 60% to a target of 35%—the approach could cut hospital readmissions, improve patient quality of life, and save the NHS significant costs. It would also shift cirrhosis management from reactive hospital care to proactive home monitoring, aligning with NHS digital health goals.
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Research Question: Is CirrhoCare, through digital-monitoring and actionable decision-making algorithms, clinically effective in reducing cirrhosis complications compared to standard-care? Background: Liver disease ranks the 3rd commonest cause of premature UK-deaths with NHS costs >£4.53bn/annum, mostly from decompensated cirrhosis complications (114,347-patients). Admissions last several weeks, requiring high-cost, intensive therapies. Following hospital-discharge, standard-outpatient follow-up occurs within 4 weeks and 8-12 weeks, thereafter. However, 37% of patients are readmitted with new complications within 4 weeks. Current care-pathways are reactive, failing to manage complications early in the community, resulting in high treatment costs, through late presentations. CirrhoCare, is a UKCA-marked, digital-therapeutic-system, consisting of clinical-grade sensors, smartphone-app and clinician-facing dashboard incorporating decision-facilitating algorithms. CirrhoCare provides proactive management, through community remote-monitoring (aligning with NHSX plans), and actionable-insights that diagnose complications early, allowing timely, cost-effective, community-interventions, for all (aligning to i4i Challenge-programme remit). Aims and Objectives: Deliver a multi-centre RCT in 214 decompensated cirrhosis patients, evaluating CirrhoCare against standard-care over 3-months; Success defined by reduction in liver-related complications requiring hospital intervention for CirrhoCare management versus Standard care-pathway. Primary Objective: To assess the clinical effectiveness of CirrhoCare s digital-therapeutic management system for cirrhosis complications, through a multi-centre RCT, with blinded outcome assessment. Secondary Objectives: Assess the cost-effectiveness of CirrhoCare implementation compared to standard care Identify the barriers to implementing CirrhoCare in real-world clinical practice Measure impacts of CirrhoCare on health-related quality-of-life and disease severity Develop the business and commercialisation strategy to implement CirrhoCare, including a stakeholder engagement plan Methods Decompensated cirrhosis patients from 12 high-volume NHS-trusts, including high BAME representation and social inequality, screened prior to hospital discharge. Main Inclusion-criteria: Adults ≥18years, any sex and racial background; cirrhosis of any aetiology; Recent hospitalization for acute decompensation (ascites, dehydration, gastrointestinal-bleed, hepatic encephalopathy, and infections); cirrhosis severity-risk defined by EF-CLIF-AD-Score >45 points. Main Exclusion-criteria: chronic comorbid diseases including cardio-pulmonary and renal failure; established malignancy; active viral infections/COVID-19; any disorders likely to impact on study engagement. Given a baseline event rate of 60%, and target treatment rate of 35% with15% loss-to-follow-up, 214 patients will be randomised (electronically-generated randomisation code), 1:1, at 90% power (alpha-5%). Patients will be followed for 3 months in Cirrhocare and standard-care arms, with telephone contacts at 4 and 8 weeks; and a clinic visit at 12 weeks. In addition, CirrhoCare managed patients will undergo daily monitoring, and 2-way communication with interventions, as clinically indicated. All hospital interventions, in both arms, will be independently adjudicated. Deliverables and Timelines: CirrhoCare technical environment-Jan-2023 Ethics and regulatory approvals-Mar-2023 Site Contracts and first patient onboarding-Apr 2023 First visit in Last patient-Jul-2024 Completion of Clinical study report, with Health economic and data analysis-Mar-2025 Commercialisation plan and regulatory dossier for NICE/HTA submissions Anticipated Impacts Patients: Decreased hospitalisation and morbidity Clinicians: Efficiencies in clinical workflow; directs attention to patients with greatest need NHS: adheres to goals of cost-effective, digi
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