Decompensated CirrhosisCirrhoCareNCT06223893
CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis
A study testing CirrhoCare management system in people with Decompensated Cirrhosis, run by University College, London at 15 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- CirrhoCare management system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 15 sitesUnited Kingdom
- Study dates
- 24 Nov 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United Kingdom15 sites, 15 recruiting
- Recruiting
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
Neil Rajoriya, Neil.Rajoriya@uhb.nhs.uk
Neil Rajoriya
- Recruiting
Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 5BE
Lucia Macken, lucia.macken@nhs.net
Lucia Macken
- Recruiting
Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX
Sophia Than, sophia.than@uhcw.nhs.uk
Sophia Than
- Recruiting
Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8YE
Omar Elshaarawy, Omar.Elshaarawy@liverpoolft.nhs.uk
Omar Elshaarawy
- Recruiting
The Royal London Hospital, Barts Health NHS Trust
London, E1 1FR
Vikram Sharma, vikram.sharma1@nhs.net
Vikram Sharma
- Recruiting
Whittington Hospital, Whittington Health NHS Trust
London, N19 5NF
Evangelia Fatourou, evangelia.fatourou@nhs.net
Evangelia Fatourou
- Recruiting
Royal Free Hospital, Royal Free London NHS Foundation Trust
London, NW3 2QG
Rajeshwar Mookerjee, r.mookerjee@ucl.ac.uk
Rajeshwar Mookerjee
- Not yet recruiting
St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
London, SE1 7EH
Giovanni Tritto, Giovanni.Tritto@gstt.nhs.uk
Giovanni Tritto
- Recruiting
King's College Hospital, King's College Hospital NHS Foundation Trust
London, SE5 9RS
Vishal Patel, vishal.patel@researchinliver.org.uk
Vishal Patel
- Recruiting
St George's Hospital, St George's university Hospital NHS Foundation Trust
London, SW17 0QT
Daniel Fortan, daniel.forton@nhs.net
Daniel Fortan, Prof
- Recruiting
Queen's Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Naaventhan Palaniyappan, Naaventhan.Palaniyappan@nottingham.ac.uk
Naaventhan Palaniyappan
- Recruiting
John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
Jeremy Cobbold, Jeremy.Cobbold@ouh.nhs.uk
Jeremy Cobbold
- Recruiting
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth, PL6 8DH
Ashwin Dhanda, ashwin.dhanda@nhs.net
Ashwin Dhanda
- Recruiting
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD
Mark Wright, mark.wright@uhs.nhs.uk
Mark Wright
- Recruiting
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Torquay, TQ2 7AA
James Neale, jamesneale@nhs.net
James Neale
About this study
Official title: 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.
Read the 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.
- Conditions
- Decompensated Cirrhosis
- Being tested
- CirrhoCare management system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CirrhoCare management systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CirrhoCare management system | Other | Not described Receives: Device: CirrhoCare management system |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days from randomisation
Secondary outcomes (13)
Effects on CLIF-C AD score
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)
Measured: 90 days from randomisation
Effects on MELD score
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]
Measured: 90 days from randomisation
To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days
To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days.
Measured: 90 days from randomisation
Healthcare resource use analysis
To assess healthcare resource use through analysis of the number of healthcare appointments during the study period
Measured: 90 days from randomisation
Healthcare cost analysis
To assess the financial costs associated with healthcare interventions during the study period (measured in British Pound Sterling).
Measured: 90 days from randomisation
User experience and engagement
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.
Measured: 90 days from randomisation
Quality of Life (EQ-5D-5L) assessment
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.
Measured: 90 days from randomisation
Frailty assessment
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.
Measured: 90 days from randomisation
Mortality
To assess mortality (overall survival)
Measured: 90 days from randomisation
Number of hospital readmissions
To assess the overall number of readmissions to hospital
Measured: 90 days from randomisation
Effects of the individual components making up the primary outcome
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]
Measured: 90 days from randomisation
Longitudinal effects of all secondary outcomes
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
Measured: Day 28, Day 56, Day 90
Length of hospital readmissions
Assessment of the length of stay for each hospital readmission for a given participant recorded in days.
Measured: 90 days from randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start24 Nov 2023
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomised 1:1 to receive either the standard of care or the CirrhoCare management system.
- Masking
- None (open label)
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- CyberLiver Ltd, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Rajeshwar Mookerjee, Study chair, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223893
- Sponsor's protocol ID
- 151197
- Acronym
- CirrhoCare
- Status last verified
- Apr 2026
- First submitted
- 31 Oct 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06223893
- Acronym / sponsor ID
- CirrhoCare / 151197
- Conditions
- Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- CyberLiver Ltd, London School of Hygiene and Tropical Medicine
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomised 1:1 to receive either the standard of care or the CirrhoCare management system.
| Arm | Type | Receives |
|---|---|---|
| CirrhoCare management system | Other | Device: CirrhoCare management system |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CirrhoCare management systemThis 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. | Device | CirrhoCare management system |
Primary outcome
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.
13 secondary outcomes
Effects on CLIF-C AD score
Time frame: 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 number of liver-related deaths at 90 days
Time frame: 90 days from randomisation
Healthcare resource use analysis
Time frame: 90 days from randomisation
Healthcare cost analysis
Time frame: 90 days from randomisation
User experience and engagement
Time frame: 90 days from randomisation
Quality of Life (EQ-5D-5L) assessment
Time frame: 90 days from randomisation
Frailty assessment
Time frame: 90 days from randomisation
Mortality
Time frame: 90 days from randomisation
Number of hospital readmissions
Time frame: 90 days from randomisation
Effects of the individual components making up the primary outcome
Time frame: 90 days from randomisation
Longitudinal effects of all secondary outcomes
Time frame: Day 28, Day 56, Day 90
Length of hospital readmissions
Time frame: 90 days from randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rajeshwar Mookerjee study chair
UCL
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CirrhoCare management system in people with Decompensated Cirrhosis, run by University College, London at 15 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tasheeka Jeyapalan (+4402076704687, cctu.cirrhocare@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hospital interventions from new-liver related complications (time frame: 90 days from randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.