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

NCT06223893 | Recruiting DMC

• 1 other identifier: 151197
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days from randomisation

Secondary Outcomes (13)

• Effects on CLIF-C AD score

  90 days from randomisation

• Effects on MELD score

  90 days from randomisation

• To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days

  90 days from randomisation

• Healthcare resource use analysis

  90 days from randomisation

• Healthcare cost analysis

  90 days from randomisation

Other Outcomes (1)

• Nutritional impact analysis

  90 days from randomisation

Study Arms (2)

CirrhoCare management system

OTHER

Device: CirrhoCare management system

Standard of Care

NO INTERVENTION

Interventions

CirrhoCare management system DEVICE

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.

CirrhoCare management system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CyberLiver Ltd: collaborator
• University College, London: lead
• London School of Hygiene and Tropical Medicine: collaborator

Study Sites (15)

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

RECRUITING

Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 5BE, United Kingdom

RECRUITING

Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

RECRUITING

Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8YE, United Kingdom

RECRUITING

The Royal London Hospital, Barts Health NHS Trust

London, E1 1FR, United Kingdom

RECRUITING

Whittington Hospital, Whittington Health NHS Trust

London, N19 5NF, United Kingdom

RECRUITING

Royal Free Hospital, Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust

London, SE1 7EH, United Kingdom

NOT YET RECRUITING

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

London, SE5 9RS, United Kingdom

RECRUITING

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

London, SW17 0QT, United Kingdom

RECRUITING

Queen's Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

RECRUITING

Derriford Hospital, University Hospitals Plymouth NHS Trust

Plymouth, PL6 8DH, United Kingdom

RECRUITING

Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

Torbay Hospital, Torbay and South Devon NHS Foundation Trust

Torquay, TQ2 7AA, United Kingdom

RECRUITING

Study Officials

• Rajeshwar Mookerjee

  UCL

  STUDY CHAIR

Central Study Contacts

Tasheeka Jeyapalan

CONTACT

+4402076704687; cctu.cirrhocare@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised 1:1 to receive either the standard of care or the CirrhoCare management system.

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: January 25, 2024
• Study Start: November 24, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

GB (15)