CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis
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
University College, London
214 participants
Nov 24, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria13
- 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.
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(15)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06223893