Using smartphone technology to improve care for patients with cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The CirrhoCare trial is a multi-centre, open label randomized controlled trial aimed at patients with decompensated cirrhosis. It investigates the clinical and cost-effectiveness of a digital home monitoring and management system compared to the current standard of care. The trial addresses the urgent need for improved management of cirrhosis, which is associated with high rates of hospital readmission and significant healthcare costs. By utilizing low-cost sensing technology to monitor vital signs and mental ability, the study seeks to enhance patient care and reduce the burden on healthcare services.

Why it matters

Who can join: the full rules

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.

Where it's running

• Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
  Birmingham, United Kingdom Recruiting
• Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
  Brighton, United Kingdom Recruiting
• Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
  Coventry, United Kingdom Recruiting
• Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
  Liverpool, United Kingdom Recruiting
• The Royal London Hospital, Barts Health NHS Trust
  London, United Kingdom Recruiting
• Whittington Hospital, Whittington Health NHS Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Tasheeka Jeyapalan
• Email: cctu.cirrhocare@ucl.ac.uk
• Phone: +4402076704687

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• FMT for decompensated cirrhosis: a multicenter phase 3 test

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.