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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06223893
Other study ID # 151197
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 24, 2023
Est. completion date May 2025

Study information

Verified date January 2024
Source University College, London
Contact Jenny Philip
Phone 0203 108 4175
Email cctu.cirrhocare@ucl.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Country Name City State
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 King's College Hospital, King's College Hospital NHS Foundation Trust London
United Kingdom Royal Free Hospital, Royal Free London NHS Foundation Trust London
United Kingdom St George's Hospital, St George's university Hospital NHS Foundation Trust London
United Kingdom St Thomas Hospital, Liverpool University Hospitals NHS Foundation Trust London
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

Sponsors (3)

Lead Sponsor Collaborator
University College, London CyberLiver Ltd, London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Nutritional impact analysis 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
Primary Number of hospital interventions from new-liver related complications 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 Effects on CLIF-C AD score 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
Secondary Effects on MELD score 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
Secondary To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 12 weeks. To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 12 weeks. 12 weeks from randomisation
Secondary Healthcare resource use analysis To assess healthcare resource use through analysis of the number of healthcare appointments during the study period 12 weeks from randomisation
Secondary Healthcare cost analysis To assess the financial costs associated with healthcare interventions during the study period (measured in British Pound Sterling). 12 weeks from randomisation
Secondary User experience and engagement 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
Secondary Quality of Life (EQ-5D-5L) assessment 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
Secondary Frailty assessment 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
Secondary Mortality To assess mortality (overall survival) 12 weeks from randomisation
Secondary Number of hospital readmissions To assess the overall number of readmissions to hospital 12 weeks from randomisation
Secondary Effects of the individual components making up the primary outcome 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
Secondary Longitudinal effects of all secondary outcomes 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
Secondary Length of hospital readmissions Assessment of the length of stay for each hospital readmission for a given participant recorded in days. 12 weeks from randomisation
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