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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-24

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Decompensated Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomised 1:1 to receive either the standard of care or the CirrhoCare management system.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CirrhoCare management system

Group Type OTHER

CirrhoCare management system

Intervention Type DEVICE

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.

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and/or histology. Cirrhosis of any aetiology may be included. However, participants with cirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for ≥3-month period before study inclusion (to be recorded on concomitant log).
3. Cirrhosis severity-risk defined by European-Foundation Consortium Liver Failure - Acute Decompensation score (CLIF-C AD score) ≥42 points but ≤65 points at the time of screening.
4. Hospitalisation for acute decompensation \[determined as one or more of the following: increasing ascites, variceal haemorrhage, overt hepatic encephalopathy, spontaneous bacterial peritonitis (SBP) or hepatorenal syndrome - acute kidney injury (HRS-AKI)\].
5. Participants able to give informed consent.

Exclusion Criteria

1. Participants with ACLF grade 2 and above according to the criteria published by Moreau
2. Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.
4. Participants with active hepatocellular carcinoma (HCC) or history of HCC that is in remission for less than six months for uninodular HCC or for less than 12 months for multinodular HCC within Milan criteria.
5. Participants with a history of significant extra hepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease with serum creatinine \>2mg/dL or under renal replacement therapy.
6. Participants with documented refractory ascites on a palliative pathway.
7. Participants who are active on the transplant waiting list.
8. Participants with current extra hepatic malignancies including solid tumours and hematologic disorders.
9. Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
10. Participants with active viral infections, or yet to achieve clear response to anti-viral therapy.
11. Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses.
12. Any other reason that the PI considers would make the participant unsuitable to enter CirrhoCare (e.g., participants on an end-of-life palliative care pathway).
13. Participants enrolled in other interventional trials.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No