- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06223893
CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis (CirrhoCare)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jenny Philip
- Phone Number: 54175 0203 108 4175
- Email: cctu.cirrhocare@ucl.ac.uk
Study Locations
-
-
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Coventry, United Kingdom, CV2 2DX
- Not yet recruiting
- Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
-
Contact:
- Sophia Than
- Email: sophia.than@uhcw.nhs.uk
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Principal Investigator:
- Sophia Than
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Liverpool, United Kingdom, L7 8YE
- Not yet recruiting
- Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
-
Contact:
- Omar Elshaarawy
- Email: Omar.Elshaarawy@liverpoolft.nhs.uk
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Principal Investigator:
- Omar Elshaarawy
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London, United Kingdom, NW3 2QG
- Recruiting
- Royal Free Hospital, Royal Free London NHS Foundation Trust
-
Contact:
- Rajeshwar Mookerjee
- Email: r.mookerjee@ucl.ac.uk
-
Principal Investigator:
- Rajeshwar Mookerjee
-
London, United Kingdom, SE1 7EH
- Not yet recruiting
- St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
-
Contact:
- Giovanni Tritto
- Email: Giovanni.Tritto@gstt.nhs.uk
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Principal Investigator:
- Giovanni Tritto
-
London, United Kingdom, SE5 9RS
- Not yet recruiting
- King's College Hospital, King's College Hospital NHS Foundation Trust
-
Contact:
- Vishal Patel
- Email: vishal.patel@researchinliver.org.uk
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Principal Investigator:
- Vishal Patel
-
London, United Kingdom, SW17 0QT
- Not yet recruiting
- St George's Hospital, St George's University Hospital NHS Foundation Trust
-
Contact:
- Daniel Fortan
- Email: daniel.forton@nhs.net
-
Principal Investigator:
- Daniel Fortan, Prof
-
Oxford, United Kingdom, OX3 9DU
- Not yet recruiting
- John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
-
Principal Investigator:
- Jeremy Cobbold
-
Contact:
- Jeremy Cobbold
- Email: Jeremy.Cobbold@ouh.nhs.uk
-
Plymouth, United Kingdom, PL6 8DH
- Not yet recruiting
- Derriford Hospital, University Hospitals Plymouth NHS Trust
-
Contact:
- Ashwin Dhanda
- Email: ashwin.dhanda@nhs.net
-
Principal Investigator:
- Ashwin Dhanda
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Southampton, United Kingdom, SO16 6YD
- Not yet recruiting
- Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
-
Contact:
- Mark Wright
- Email: mark.wright@uhs.nhs.uk
-
Principal Investigator:
- Mark Wright
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 stable corticosteroid dose for ≥3-month period before study inclusion.
- Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥45 but <60 points at the time of screening.
- Hospitalisation for acute decompensation (determined as one or more of the following: increasing ascites, portal hypertensive-related bleeding, overt hepatic encephalopathy, new infection).
- Participants able to give informed consent.
Exclusion Criteria:
- Participants with ACLF grade 2 and above according to the criteria published by Moreau 1
- Participants with CLIF-C AD score ≥ 60, who have a high mortality similar to ACLF ≥2 participants. 2
- Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification 3, 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 4, COPD GOLD >2, chronic kidney disease with serum creatinine >2mg/dL or under renal replacement therapy.
- Participants with documented refractory ascites, and who are being considered for liver transplantation listing.
- Participants with current extra hepatic malignancies including solid tumours and hematologic disorders.
- Participants with mental incapacity, language barrier, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study (e.g., severe addiction and relapse history).
- 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 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).
- Refusal or inability to give informed consent.
- Participants enrolled in other interventional trials.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard of Care
|
|
Other: CirrhoCare management system
|
This is a UKCA-marked, digital-therapeutic system consisting of:
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of hospital interventions from new-liver related complications
Time Frame: 12 weeks from randomisation
|
The CirrhoCare trial will investigate whether the CirrhoCare management system leads to a reduction in the requirement for hospital intervention from new-liver related complications over 12 weeks from randomisation.
|
12 weeks from randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects on CLIF-C AD score
Time Frame: 12 weeks from randomisation
|
To determine the effects of the CirrhoCare management system on the Chronic Liver Failure Consortium Acute Decompensation (CLIF-C AD) score.
[Minimum score is 0 and there is no upper limit.
The higher the score the worse the outcome)
|
12 weeks from randomisation
|
Effects on MELD score
Time Frame: 12 weeks from randomisation
|
To determine the effects of the CirrhoCare management system on the Model for End-Stage Liver Disease score ( MELD).
[Score ranges from 6-40.
The higher the score the worse the outcome]
|
12 weeks from randomisation
|
To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 12 weeks.
Time Frame: 12 weeks from randomisation
|
To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 12 weeks.
|
12 weeks from randomisation
|
Healthcare resource use analysis
Time Frame: 12 weeks from randomisation
|
To assess healthcare resource use through analysis of the number of healthcare appointments during the study period
|
12 weeks from randomisation
|
Healthcare cost analysis
Time Frame: 12 weeks from randomisation
|
To assess the financial costs associated with healthcare interventions during the study period (measured in British Pound Sterling).
|
12 weeks from randomisation
|
User experience and engagement
Time Frame: 12 weeks from randomisation
|
To assess user experience and engagement through questionnaires and interviews : The questionnaires will be graded from 1-10 for each question, with 0 is extremely negative as a response, and 10 very highly positive response.
|
12 weeks from randomisation
|
Quality of Life (EQ-5D-5L) assessment
Time Frame: 12 weeks from randomisation
|
To assess health-related quality of Life through the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
The score ranges from -0.59 to 1, with a score of 1 representing the best possible health status.
|
12 weeks from randomisation
|
Frailty assessment
Time Frame: 12 weeks from randomisation
|
To assess frailty using the Liver Frailty Index.
The score ranges from 1.0 to 7.0 with higher scores representing increased levels of frailty.
|
12 weeks from randomisation
|
Mortality
Time Frame: 12 weeks from randomisation
|
To assess mortality (overall survival)
|
12 weeks from randomisation
|
Number of hospital readmissions
Time Frame: 12 weeks from randomisation
|
To assess the overall number of readmissions to hospital
|
12 weeks from randomisation
|
Effects of the individual components making up the primary outcome
Time Frame: 12 weeks from randomisation
|
Assessment of the effects of the individual components making up the primary outcome.
Each complication of cirrhosis will be individually assessed between CirrhoCare and standard of care groups.
[Ascites based on Gr 1-3 and HE based on West Haven criteria 1-4; Infection Positive or Negative culture]
|
12 weeks from randomisation
|
Longitudinal effects of all secondary outcomes
Time Frame: Week 4, week 8 and week 12
|
The longitudinal effects of all secondary outcomes will be investigated by using an appropriate model that incorporates the week 4 and week 8 visits in addition to the week 12
|
Week 4, week 8 and week 12
|
Length of hospital readmissions
Time Frame: 12 weeks from randomisation
|
Assessment of the length of stay for each hospital readmission for a given participant recorded in days.
|
12 weeks from randomisation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional impact analysis
Time Frame: 12 weeks from randomisation
|
To assess whether there is a change in nutritional status using the Royal Free Hospital Nutrition Prioritizing Tool (RFH-NPT).
The score ranges from 0-7, with higher scores being associated with an increased risk of malnutrition.
|
12 weeks from randomisation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Rajeshwar Mookerjee, UCL
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 151197
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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