CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis
- Conditions
- Decompensated Cirrhosis
- Interventions
- Device: CirrhoCare management system
- Registration Number
- NCT06223893
- Lead Sponsor
- University College, London
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 214
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CirrhoCare management system CirrhoCare management system -
- Primary Outcome Measures
Name Time Method Number of hospital interventions from new-liver related complications 90 days from randomisation The CirrhoCare trial will investigate whether the CirrhoCare management system leads to a reduction in the requirement for unplanned medical intervention from new-liver related complications over 90 days from hospital discharge.
- Secondary Outcome Measures
Name Time Method Number of hospital readmissions 90 days from randomisation To assess the overall number of readmissions to hospital
Healthcare resource use analysis 90 days from randomisation To assess healthcare resource use through analysis of the number of healthcare appointments during the study period
Healthcare cost analysis 90 days from randomisation To assess the financial costs associated with healthcare interventions during the study period (measured in British Pound Sterling).
User experience and engagement 90 days 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.
Effects of the individual components making up the primary outcome 90 days 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. \[Ascites based on Gr 1-3 and HE based on West Haven criteria 1-4; Infection Positive or Negative culture\]
Longitudinal effects of all secondary outcomes Day 28, Day 56, Day 90 The longitudinal effects of all secondary outcomes will be investigated by using an appropriate model that incorporates the Day 28 and Day 56 visits in addition to the Day 90 visit
Length of hospital readmissions 90 days from randomisation Assessment of the length of stay for each hospital readmission for a given participant recorded in days.
Quality of Life (EQ-5D-5L) assessment 90 days 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.
Frailty assessment 90 days 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.
Mortality 90 days from randomisation To assess mortality (overall survival)
Effects on CLIF-C AD score 90 days 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)
Effects on MELD score 90 days from randomisation To determine the effects of the CirrhoCare management system on the Model for End-Stage Liver Disease score ( MELD). \[Score ranges from 6-40. The higher the score the worse the outcome\]
To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days 90 days from randomisation To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days.
Trial Locations
- Locations (15)
Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
🇬🇧Brighton, United Kingdom
Walsgrave General Hospital, University Hospital Coventry & Warwickshire NHS Trust
🇬🇧Coventry, United Kingdom
Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
The Royal London Hospital, Barts Health NHS Trust
🇬🇧London, United Kingdom
Whittington Hospital, Whittington Health NHS Trust
🇬🇧London, United Kingdom
Royal Free Hospital, Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
King's College Hospital, King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
St George's Hospital, St George's university Hospital NHS Foundation Trust
🇬🇧London, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
John Radcliff Hospital, Oxford University Hospitals NHS Foundation Trust
🇬🇧Oxford, United Kingdom
Derriford Hospital, University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, United Kingdom
Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
Torbay Hospital, Torbay and South Devon NHS Foundation Trust
🇬🇧Torquay, United Kingdom