CirrhoCare during COVID-19 [COVID-19]

  • Research type

    Research Study

  • Full title

    Remote home monitoring of patients with advanced cirrhosis during COVID-19 to diagnose early and severe cirrhosis decompensation

  • IRAS ID

    285666

  • Contact name

    Raj Mookerjee

  • Contact email

    r.mookerjee@ucl.ac.uk

  • Sponsor organisation

    Royal Free London NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT05045924

  • Duration of Study in the UK

    0 years, 6 months, 0 days

  • Research summary

    The current Covid Pandemic has necessitated an unusual allocation of healthcare resources which inevitably, negatively impacts on resources available to care for patients with chronic diseases including liver disease, who still require high levels of medical oversight.\n\n This is most marked in those with acute ‘decompensation’ of cirrhosis, namely the patients who develop a rapid decline in liver function and numerous complications including, fluid overload, confusion (encephalopathy), kidney dysfunction and gastrointestinal bleeding.\n\nThese patients normally require a regular clinical assessment (every 1-2 weeks) and even when discharged following a recent admission to hospital, have re-admission rates approaching 40% in 8 weeks.\n\n The current unmet need is to have regular contact with the patient, to avoid further new complications from cirrhosis developing and hospital admission, whilst also avoiding the possibility of the patients being infected with Covid 19 through standard outpatient, scheduled contact. \n\nThis study is proposing to use a remote management system for cirrhosis care, which will include remote monitoring of important vital signs such as heart rate, heart rate variability, blood pressure, physical activity and sleep status (through wearable technology), weight, and assessment of higher mental function (smartphone app based tools). It is hoped that the use of smart technology, that this patients can be monitored to allow early detection of signs of complications and rapid triaging of patients who need early direct clinical review, at a time when this is a limited resource. This will ensure that our patients can still be safely monitored and their COVID-19 exposure risk is reduced.\n

  • REC name

    London - Brighton & Sussex Research Ethics Committee

  • REC reference

    20/HRA/3843

  • Date of REC Opinion

    24 Aug 2020

  • REC opinion

    Further Information Favourable Opinion