Greenham Olivia, Gananandan Kohilan, Balaji Anu, Kazankov Konstantin, Thomsen Karen L, Bamber Jonathan, Philip Jenny, Wadke Anvi, Sadique Zia, Raja Maruthi, Boddu Ravan, Kumar Ravi, Jalan Rajiv, Mookerjee Rajeshwar P
Liver Failure Group, UCL Institute for Liver & Digestive Health, London, UK.
CyberLiver Limited, London, UK.
BMJ Open. 2025 Jul 6;15(7):e098725. doi: 10.1136/bmjopen-2024-098725.
Liver cirrhosis accounts for over 10 000 deaths in the UK each year with a total loss of 60 000 quality-adjusted life-years. There is a substantial cost to the NHS of £4.5 billion, with new liver-related decompensation events accounting for the majority of this. Following an acute cirrhosis decompensating event, there is a significant risk of hospital readmission with 90-day readmission rates as high as 53%. Current care in the UK is reactive and patients are often only readmitted when they have presented acutely as an emergency with significant decompensation.
CirrhoCare is a prospective, multicentre, randomised controlled trial comparing the CirrhoCare management system with standard-of-care for high-risk cirrhosis patients who have been discharged following an admission with acute decompensation. The CirrhoCare management system comprises a novel digital platform for use in a patient's home, designed to proactively detect the first signs of new decompensation in patients with established cirrhosis, discharged to the community. This enables a clinician to instigate early community-based care or, if needed, to triage the patient for hospital interventions.214 patients will be recruited to the CirrhoCare trial from at least 12 UK centres. Patients will be randomised on a 1:1 ratio allocation to the CirrhoCare Management System or standard of care. Participants who are randomised to CirrhoCare will receive a CirrhoCare health kit comprising a smart watch, smart phone with enabled SIM (Subscriber Identity Module) network card, blood pressure monitor, weighing scales and thermometer. Participants will take measurements every morning Monday to Friday and will be followed up for 90 days postdischarge.The primary objective of this study is to assess the clinical effectiveness of the CirrhoCare digital management system. We hypothesise that its early community-based intervention will reduce the number of unplanned hospital interventions and admissions and prevent liver-related complications when compared with standard-of-care management.
CirrhoCare is a National Institute for Health and Care Research-funded study (NCT06223893). The study has UK Research Ethics Committee and Health Research Authority (HRA) approvals, with approval granted by the HRA and Health and Care Research Wales committee. The results of this study will be published in peer review journals, disseminated at international conferences as well as established Patient and Public Involvement and Engagement networks.
ISRCTN11380842.
在英国，肝硬化每年导致超过10000人死亡，总共损失60000个质量调整生命年。国民保健制度为此付出了45亿英镑的巨大成本，其中大部分是由新的肝脏相关失代偿事件造成的。在急性肝硬化失代偿事件发生后，再次入院的风险很高，90天再入院率高达53%。英国目前的治疗是被动反应式的，患者通常只有在因严重失代偿而紧急就诊时才会再次入院。
CirrhoCare是一项前瞻性、多中心、随机对照试验，将CirrhoCare管理系统与急性失代偿入院后出院的高危肝硬化患者的标准治疗进行比较。CirrhoCare管理系统包括一个用于患者家中的新型数字平台，旨在主动检测已确诊肝硬化且已出院至社区的患者新失代偿的最初迹象。这使临床医生能够启动早期社区护理，或者在需要时将患者分诊以进行医院干预。将从英国至少12个中心招募214名患者参加CirrhoCare试验。患者将按1:1的比例随机分配到CirrhoCare管理系统或标准治疗组。随机分配到CirrhoCare的参与者将获得一个CirrhoCare健康套件，包括一块智能手表、一张带有启用了SIM（用户识别模块）网卡的智能手机、一个血压监测仪、体重秤和温度计。参与者将在周一至周五每天早上进行测量，并在出院后随访90天。本研究的主要目的是评估CirrhoCare数字管理系统的临床有效性。我们假设，与标准治疗管理相比，其早期社区干预将减少计划外的医院干预和入院次数，并预防肝脏相关并发症。
CirrhoCare是一项由英国国家卫生与保健研究所资助的研究（NCT06223893）。该研究已获得英国研究伦理委员会和健康研究管理局（HRA）的批准，HRA以及威尔士健康与护理研究委员会也已批准。本研究结果将发表在同行评审期刊上，在国际会议上传播，并通过已建立的患者和公众参与及参与网络进行传播。
ISRCTN11380842。
