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

Last updated: May 1, 2025
Sponsor: University College, London
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Hepatic Fibrosis

Hyponatremia

Treatment

CirrhoCare management system

Clinical Study ID

NCT06223893
151197
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion criteria:

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

  2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/orhistology. Cirrhosis of any aetiology may be included. However, participants withcirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for ≥3-month period before study inclusion (to be recorded on concomitant log).

  3. Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure -Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65 points at the timeof screening.

  4. Hospitalisation for acute decompensation [determined as one or more of thefollowing: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy,spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome - acute kidneyinjury (HRS-AKI)].

  5. Participants able to give informed consent.

Exclusion

Exclusion criteria:

  1. Participants with ACLF grade 2 and above according to the criteria published byMoreau

  2. Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2participants.

  3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathyaccording to the West-Haven classification, unable to give consent.

  4. Participants with active hepatocellular carcinoma (HCC) or history of HCC that is inremission for less than six months for uninodular HCC or for less than 12 months formultinodular HCC within Milan criteria.

  5. Participants with a history of significant extra hepatic disease with impairedshort-term prognosis, including congestive heart failure New York Heart AssociationGrade III/IV, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL orunder renal replacement therapy.

  6. Participants with documented refractory ascites

  7. Participants who are active on the transplant waiting list.

  8. Participants with current extra hepatic malignancies including solid tumours andhematologic disorders.

  9. Participants with mental incapacity, significant language barriers, or any otherreason considered by the investigator precluding adequate understanding, cooperationor compliance in the study.

  10. Participants with active viral infections, or yet to achieve clear response toanti-viral therapy.

  11. Any disorders likely to impact on study engagement, including severe frailty, severeaddiction history (including opioids) with evidence of multiple recent relapses.

  12. Any other reason that the PI considers would make the participant unsuitable toenter CirrhoCare (e.g., participants on an end-of-life palliative care pathway).

  13. Participants enrolled in other interventional trials.

Study Design

Total Participants: 214
Treatment Group(s): 1
Primary Treatment: CirrhoCare management system
Phase:
Study Start date:
November 24, 2023
Estimated Completion Date:
November 30, 2025

Study Description

Cirrhosis, progressive scaring of the liver- has many causes, principally, excessive alcohol intake, fatty-liver and viral infections. Unlike many chronic diseases, cirrhosis deaths are increasing rapidly year-on-year. It is the third commonest cause of premature, UK working-age deaths, with 62,000 years of working-life lost each year and NHS care costs of £4.53bn annually. One quarter of all UK cirrhosis patients are at-risk of acute decompensation, whereby complications such as fluid-overload, confusion and infections arise, requiring hospital-emergency treatment.

Currently, decompensated cirrhosis patients require regular hospital clinical assessments to detect these new complications. Even following hospital discharge, readmission with new decompensating complications approaches 37% in 4 weeks. This disease burden, compounded by increasing alcohol and obesity-driven liver disease, means demand for specialist liver services outweighs current capacity in a resource-stretched healthcare system. Moreover, regional variation of specialist liver services also impacts on illness and deaths, leading to a postcode lottery of care access and geographical inequity.

The CirrhoCare trial, addresses this urgent clinical-need through an innovative cirrhosis management system, including home-monitoring of decompensated cirrhosis patients, measuring vital signs such as heart rate and blood pressure (using low cost, sensing technology), assessing weight (smart-scale) and mental ability (smartphone app), all of which are impacted as cirrhosis progresses. By efficiently and securely collecting data on CyberLiver's management-system (platform), CirrhoCare provides a decision-facilitating tool, incorporating individual-patient data, helping liver-physicians to optimise and personalise treatment in the community.

The CirrhoCare trial investigators also plan to assess clinical and cost effectiveness of CirrhoCare management and seek regulatory approvals. This innovative aspect of cirrhosis management will be more acceptable and convenient for patients. It will also deliver community care with environmental, sustainable benefits, through reduced hospital visits, despite increasing service demands. The cost- effectiveness analysis will generate value-for-money evidence of CirrhoCare management, and the clinical evidence needed to inform future adoption into the NHS.

Connect with a study center

  • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust

    Brighton, BN2 5BE
    United Kingdom

    Active - Recruiting

  • Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust

    Coventry, CV2 2DX
    United Kingdom

    Active - Recruiting

  • Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8YE
    United Kingdom

    Active - Recruiting

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

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital, Royal Free London NHS Foundation Trust

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

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

    London, SW17 0QT
    United Kingdom

    Active - Recruiting

  • St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • The Royal London Hospital, Barts Health NHS Trust

    London, E1 1FR
    United Kingdom

    Active - Recruiting

  • Whittington Hospital, Whittington Health NHS Trust

    London, N19 5NF
    United Kingdom

    Active - Recruiting

  • Queen's Medical Centre, Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Active - Recruiting

  • Derriford Hospital, University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Torbay Hospital, Torbay and South Devon NHS Foundation Trust

    Torquay, TQ2 7AA
    United Kingdom

    Active - Recruiting

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