RecruitingNot ApplicableNCT06223893

CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis

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


Sponsor

University College, London

Enrollment

214 participants

Start Date

Nov 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 able to give informed consent.

Exclusion Criteria13

  • 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.
  • Participants with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
  • Participants with documented refractory ascites on a palliative pathway.
  • Participants who are active on the transplant waiting list.
  • Participants with current extra hepatic malignancies including solid tumours and hematologic disorders.
  • Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
  • Participants with active viral infections, or yet to achieve clear response to anti-viral therapy.
  • Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses.
  • Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway).
  • Participants enrolled in other interventional trials.

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Interventions

DEVICECirrhoCare management system

This 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.


Locations(15)

The Royal London Hospital, Barts Health NHS Trust

London, London, United Kingdom

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust

Brighton, United Kingdom

Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust

Coventry, United Kingdom

Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Whittington Hospital, Whittington Health NHS Trust

London, United Kingdom

Royal Free Hospital, Royal Free London NHS Foundation Trust

London, United Kingdom

St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust

London, United Kingdom

King's College Hospital, King's College Hospital NHS Foundation Trust

London, United Kingdom

St George's Hospital, St George's university Hospital NHS Foundation Trust

London, United Kingdom

Queen's Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Derriford Hospital, University Hospitals Plymouth NHS Trust

Plymouth, United Kingdom

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Torbay Hospital, Torbay and South Devon NHS Foundation Trust

Torquay, United Kingdom

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