Actively Recruiting
CirrhoCare, A Real-world, Randomised Controlled Study to Determine Clinical and Cost-effectiveness of CirrhoCare Digital Home Monitoring and Management in Patients With Decompensated Cirrhosis
Led by University College, London · Updated on 2026-05-07
214
Participants Needed
15
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
C
CyberLiver Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new digital home monitoring and management system called CirrhoCare for patients with decompensated cirrhosis, a serious liver condition caused by scarring from factors such as alcohol, fatty liver, and viral infections. This trial aims to assess the clinical and cost-effectiveness of CirrhoCare compared to the current standard of care. Cirrhosis leads to serious complications and frequent hospital visits, and this study addresses the need for better community-based care through innovative technology. The CirrhoCare system includes clinical-grade monitoring devices such as an Apple watch, a smartphone app, a blood pressure monitor, a weighing scale, and a thermometer. These devices collect vital signs and other health data daily, which are securely transmitted to a clinical dashboard. The system uses hepatic algorithms to help liver specialists identify risks and personalize treatment. Participants are randomly assigned to either receive this digital monitoring system or continue with standard care. Participants will be involved for at least 90 days after randomization, during which researchers will monitor hospital interventions, liver-related complications, hospital readmissions, mortality, quality of life, frailty, and user experience. Data will be collected through the app and clinical assessments to evaluate the effectiveness of CirrhoCare. The study also includes health economic analyses to determine cost-effectiveness and aims to support future adoption of this technology in healthcare services.
CONDITIONS
Brief Title
CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older diagnosed with cirrhosis of any cause
- Cirrhosis defined by clinical criteria, ultrasound, or biopsy
- Cirrhosis severity with CLIF-C AD score between 42 and 65 at screening
- Hospitalized for acute decompensation such as ascites, variceal bleeding, hepatic encephalopathy, bacterial infection, or kidney injury
- Able to provide informed consent
You will not qualify if you...
- Participants with acute-on-chronic liver failure grade 2 or higher
- CLIF-C AD score 66 or above at screening
- Current overt hepatic encephalopathy grade II to IV preventing consent
- Active liver cancer or recent remission less than 6 months (uninodular) or 12 months (multinodular)
- Significant other diseases with poor short-term prognosis including severe heart failure, COPD, or advanced kidney disease
- Refractory ascites on palliative care pathway
- On active liver transplant waiting list
- Current extrahepatic cancers
- Mental incapacity or language barriers preventing study participation
- Active viral infections without clear response to treatment
- Severe frailty or history of severe addiction with recent relapses
- Other reasons deemed unsuitable by the investigator
- Enrolled in other interventional trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days from randomisation
Participants use the CirrhoCare management system, a digital-therapeutic device with sensors and an app to monitor cirrhosis at home, helping clinicians optimize treatment.
Daily monitoring via device and smartphone app
Duration - 90 days from randomisation
Participants' health status and outcomes are monitored remotely during and after using the CirrhoCare system to assess clinical and cost-effectiveness.
Assessments at Day 28, Day 56, and Day 90
Trial Site Locations
Total: 15 locations
1
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
2
Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
3
Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
Coventry, United Kingdom, CV2 2DX
Actively Recruiting
4
Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L7 8YE
Actively Recruiting
5
The Royal London Hospital, Barts Health NHS Trust
London, United Kingdom, E1 1FR
Actively Recruiting
6
Whittington Hospital, Whittington Health NHS Trust
London, United Kingdom, N19 5NF
Actively Recruiting
7
Royal Free Hospital, Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Actively Recruiting
8
St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
London, United Kingdom, SE1 7EH
Not Yet Recruiting
9
King's College Hospital, King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Actively Recruiting
10
St George's Hospital, St George's university Hospital NHS Foundation Trust
London, United Kingdom, SW17 0QT
Actively Recruiting
11
Queen's Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
12
John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU
Actively Recruiting
13
Derriford Hospital, University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
14
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
15
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom, TQ2 7AA
Actively Recruiting
Research Team
T
Tasheeka Jeyapalan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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