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

Last updated: January 16, 2024
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
  • Accepts Healthy Volunteers

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 stable corticosteroid dose for ≥3-month period before study inclusion.
  3. Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure -Acute Decompensation score (CLIF-C AD score) ≥45 but <60 points at the time ofscreening.
  4. Hospitalisation for acute decompensation (determined as one or more of the following:increasing ascites, portal hypertensive-related bleeding, overt hepaticencephalopathy, new infection).
  5. Participants able to give informed consent.

Exclusion

Exclusion Criteria:

  1. Participants with ACLF grade 2 and above according to the criteria published by Moreau 1
  2. Participants with CLIF-C AD score ≥ 60, who have a high mortality similar to ACLF ≥2participants. 2
  3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathyaccording to the West-Haven classification 3, 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 4, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL orunder renal replacement therapy.
  6. Participants with documented refractory ascites, and who are being considered forliver transplantation listing.
  7. Participants with current extra hepatic malignancies including solid tumours andhematologic disorders.
  8. Participants with mental incapacity, language barrier, or any other reason consideredby the investigator precluding adequate understanding, cooperation or compliance inthe study (e.g., severe addiction and relapse history).
  9. Participants with active viral infections, or yet to achieve clear response toanti-viral therapy.
  10. Any disorders likely to impact on study engagement, including severe frailty, severeaddiction history (including opioids) with evidence of multiple relapses.
  11. Any other reason that the PI considers would make the participant unsuitable to enterCirrhoCare (e.g., participants on an end-of-life palliative care pathway).
  12. Refusal or inability to give informed consent.
  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:
May 31, 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

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

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

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

    Liverpool, L7 8YE
    United Kingdom

    Site Not Available

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

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • 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

    Site Not Available

  • St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust

    London, SE1 7EH
    United Kingdom

    Site Not Available

  • John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU
    United Kingdom

    Site Not Available

  • Derriford Hospital, University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

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