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RECRUITING
NCT06223893
NA

CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis

Sponsor: University College, London

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2023-11-24

Completion Date

2025-11

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

DEVICE

CirrhoCare 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)

The Royal London Hospital, Barts Health NHS Trust

London, London, United Kingdom

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

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