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Using smartphone technology to improve care for patients with 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

Not applicable Interventional University College, London · NCT06223893

This study is testing whether a new smartphone monitoring system can help people with advanced liver disease manage their condition better and avoid hospital visits compared to regular care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment214 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity College, London Academic / other
Locations15 sites (Birmingham and 14 other locations)
Trial IDNCT06223893 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with cirrhosis of any cause, who have experienced acute decompensation.

Not a fit: Patients with advanced cirrhosis (ACLF grade 2 and above) may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the management of cirrhosis, leading to better patient outcomes and reduced hospitalizations.

How similar studies have performed: Other studies have shown promise in using digital health technologies for chronic disease management, indicating potential success for this novel approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham and 14 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Decompensated Cirrhosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.