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

April 30, 2026 updated by: University College, London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Neil Rajoriya
      • Brighton, United Kingdom, BN2 5BE
        • Recruiting
        • Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Lucia Macken
      • Coventry, United Kingdom, CV2 2DX
        • Recruiting
        • Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
        • Contact:
        • Principal Investigator:
          • Sophia Than
      • Liverpool, United Kingdom, L7 8YE
        • Recruiting
        • Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Omar Elshaarawy
      • London, United Kingdom, E1 1FR
        • Recruiting
        • The Royal London Hospital, Barts Health NHS Trust
        • Contact:
        • Principal Investigator:
          • Vikram Sharma
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital, Royal Free London NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Rajeshwar Mookerjee
      • London, United Kingdom, SE1 7EH
        • Not yet recruiting
        • St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Giovanni Tritto
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital, King's College Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Vishal Patel
      • London, United Kingdom, N19 5NF
        • Recruiting
        • Whittington Hospital, Whittington Health NHS Trust
        • Contact:
        • Principal Investigator:
          • Evangelia Fatourou
      • London, United Kingdom, SW17 0QT
        • Recruiting
        • St George's Hospital, St George's university Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Daniel Fortan, Prof
      • Nottingham, United Kingdom, NG7 2UH
        • Recruiting
        • Queen's Medical Centre, Nottingham University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Naaventhan Palaniyappan
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Jeremy Cobbold
        • Contact:
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Derriford Hospital, University Hospitals Plymouth NHS Trust
        • Contact:
        • Principal Investigator:
          • Ashwin Dhanda
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Mark Wright
      • Torquay, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay Hospital, Torbay and South Devon NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • James Neale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
  2. 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).
  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 time of screening.
  4. 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)].
  5. Participants able to give informed consent.

Exclusion criteria:

  1. Participants with ACLF grade 2 and above according to the criteria published by Moreau
  2. Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
  3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.
  4. 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.
  5. 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.
  6. Participants with documented refractory ascites on a palliative pathway.
  7. Participants who are active on the transplant waiting list.
  8. Participants with current extra hepatic malignancies including solid tumours and hematologic disorders.
  9. Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
  10. Participants with active viral infections, or yet to achieve clear response to anti-viral therapy.
  11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses.
  12. 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).
  13. Participants enrolled in other interventional trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Other: CirrhoCare management system
Device: CirrhoCare 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of hospital interventions from new-liver related complications
Time Frame: 90 days from randomisation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on CLIF-C AD score
Time Frame: 90 days from randomisation
To determine the effects of the CirrhoCare management system on the Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score. [Minimum score is 0 and there is no upper limit. The higher the score the worse the outcome)
90 days from randomisation
Effects on MELD score
Time Frame: 90 days from randomisation
To determine the effects of the CirrhoCare management system on the Model for End-Stage Liver Disease score ( MELD). [Score ranges from 6-40. The higher the score the worse the outcome]
90 days from randomisation
To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days
Time Frame: 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
Time Frame: 90 days from randomisation
To assess healthcare resource use through analysis of the number of healthcare appointments during the study period
90 days from randomisation
Healthcare cost analysis
Time Frame: 90 days from randomisation
To assess the financial costs associated with healthcare interventions during the study period (measured in British Pound Sterling).
90 days from randomisation
User experience and engagement
Time Frame: 90 days from randomisation
To assess user experience and engagement through questionnaires and interviews : The questionnaires will be graded from 1-10 for each question, with 0 is extremely negative as a response, and 10 very highly positive response.
90 days from randomisation
Quality of Life (EQ-5D-5L) assessment
Time Frame: 90 days from randomisation
To assess health-related quality of Life through the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The score ranges from -0.59 to 1, with a score of 1 representing the best possible health status.
90 days from randomisation
Frailty assessment
Time Frame: 90 days from randomisation
To assess frailty using the Liver Frailty Index. The score ranges from 1.0 to 7.0 with higher scores representing increased levels of frailty.
90 days from randomisation
Mortality
Time Frame: 90 days from randomisation
To assess mortality (overall survival)
90 days from randomisation
Number of hospital readmissions
Time Frame: 90 days from randomisation
To assess the overall number of readmissions to hospital
90 days from randomisation
Effects of the individual components making up the primary outcome
Time Frame: 90 days from randomisation
Assessment of the effects of the individual components making up the primary outcome. Each complication of cirrhosis will be individually assessed between CirrhoCare and standard of care groups. [Ascites based on Gr 1-3 and HE based on West Haven criteria 1-4; Infection Positive or Negative culture]
90 days from randomisation
Longitudinal effects of all secondary outcomes
Time Frame: Day 28, Day 56, Day 90
The longitudinal effects of all secondary outcomes will be investigated by using an appropriate model that incorporates the Day 28 and Day 56 visits in addition to the Day 90 visit
Day 28, Day 56, Day 90
Length of hospital readmissions
Time Frame: 90 days from randomisation
Assessment of the length of stay for each hospital readmission for a given participant recorded in days.
90 days from randomisation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional impact analysis
Time Frame: 90 days from randomisation
To assess whether there is a change in nutritional status using the Royal Free Hospital Nutrition Prioritizing Tool (RFH-NPT). The score ranges from 0-7, with higher scores being associated with an increased risk of malnutrition.
90 days from randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

London School of Hygiene and Tropical Medicine
CyberLiver Ltd

Investigators

  • Study Chair: Rajeshwar Mookerjee, UCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2023

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151197

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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