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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 214
- 试验地点
- 15
- 主要终点
- Number of hospital interventions from new-liver related complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years and diagnosed with cirrhosis of any aetiology.
- •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).
- •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.
- •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)].
- •Participants able to give informed consent.
排除标准
- •Participants with ACLF grade 2 and above according to the criteria published by Moreau
- •Participants with CLIF-C AD score ≥ 66, who have a high mortality similar to ACLF ≥2 participants.
- •Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification, unable to give consent.
- •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.
- •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.
- •Participants with documented refractory ascites on a palliative pathway.
- •Participants who are active on the transplant waiting list.
- •Participants with current extra hepatic malignancies including solid tumours and hematologic disorders.
- •Participants with mental incapacity, significant language barriers, or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.
- •Participants with active viral infections, or yet to achieve clear response to anti-viral therapy.
- •Any disorders likely to impact on study engagement, including severe frailty, severe addiction history (including opioids) with evidence of multiple recent relapses.
- •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).
- •Participants enrolled in other interventional trials.
研究组 & 干预措施
CirrhoCare management system
干预措施: CirrhoCare management system (Device)
Standard of Care
结局指标
主要结局
Number of hospital interventions from new-liver related complications
时间窗: 90 days from randomisation
The CirrhoCare trial will investigate whether the CirrhoCare management system leads to a reduction in the requirement for unplanned medical intervention from new-liver related complications over 90 days from hospital discharge.
次要结局
- Number of hospital readmissions(90 days from randomisation)
- Healthcare resource use analysis(90 days from randomisation)
- Healthcare cost analysis(90 days from randomisation)
- User experience and engagement(90 days from randomisation)
- Quality of Life (EQ-5D-5L) assessment(90 days from randomisation)
- Frailty assessment(90 days from randomisation)
- Mortality(90 days from randomisation)
- Effects on CLIF-C AD score(90 days from randomisation)
- Effects on MELD score(90 days from randomisation)
- To determine the effects of the CirrhoCare management system on the number of liver-related deaths at 90 days(90 days from randomisation)
- Effects of the individual components making up the primary outcome(90 days from randomisation)
- Longitudinal effects of all secondary outcomes(Day 28, Day 56, Day 90)
- Length of hospital readmissions(90 days from randomisation)