RecruitingNot ApplicableNCT06223893

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


Sponsor

University College, London

Enrollment

214 participants

Start Date

Nov 24, 2023

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CirrhoCare management system for people with decompensated cirrhosis. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECirrhoCare management system

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)

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

View Full Details on ClinicalTrials.gov

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NCT06223893


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