Clinical trial NCT06223893: CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decompensated Cirrhosis
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: CyberLiver Ltd
name: London School of Hygiene and Tropical Medicine
First posted: 2024-01-25
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised 1:1 to receive either the standard of care or the CirrhoCare management system.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of hospital interventions from new-liver related complications
timeFrame: 90 days from randomisation
Secondary outcomes:
measure: Effects on CLIF-C AD score
timeFrame: 90 days from randomisation
measure: Effects on MELD score
timeFrame: 90 days from randomisation
measure: To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days
timeFrame: 90 days from randomisation
measure: Healthcare resource use analysis
timeFrame: 90 days from randomisation
measure: Healthcare cost analysis
timeFrame: 90 days from randomisation
measure: User experience and engagement
timeFrame: 90 days from randomisation
measure: Quality of Life (EQ-5D-5L) assessment
timeFrame: 90 days from randomisation
measure: Frailty assessment
timeFrame: 90 days from randomisation
measure: Mortality
timeFrame: 90 days from randomisation
measure: Number of hospital readmissions
timeFrame: 90 days from randomisation
measure: Effects of the individual components making up the primary outcome
timeFrame: 90 days from randomisation
measure: Longitudinal effects of all secondary outcomes
timeFrame: Day 28, Day 56, Day 90
measure: Length of hospital readmissions
timeFrame: 90 days from randomisation
Other outcomes:
measure: Nutritional impact analysis
timeFrame: 90 days from randomisation
Locations:
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
city: Coventry
country: United Kingdom
facility: Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: The Royal London Hospital, Barts Health NHS Trust
city: London
country: United Kingdom
facility: Whittington Hospital, Whittington Health NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital, Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital, King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's Hospital, St George's university Hospital NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre, Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
city: Plymouth
country: United Kingdom
facility: Derriford Hospital, University Hospitals Plymouth NHS Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
city: Torquay
country: United Kingdom
facility: Torbay Hospital, Torbay and South Devon NHS Foundation Trust
Study officials:
affiliation: UCL
name: Rajeshwar Mookerjee
role: STUDY_CHAIR
References: