nephrology, Assistance Publique - Hopitaux de Paris, Paris, France.
University of Paris, Paris, France
BMJ Open. 2022 Dec 9;12(12):e062613. doi: 10.1136/bmjopen-2022-062613.
End-stage renal disease (ESRD) affects 84 000 persons in France and costs an estimated €4.2 billion. Education about their disease empowers patients and allows improved management of their disease and better health outcomes. This study aims to explore whether the addition of an interactive web-based platform to patient education is effective and cost-effective and additionally whether complementing the platform with social functions and features improves its performance.
Patients with severe, ESRD or post-transplant will be randomised 1:1:1 to either standard therapeutic education; or education using a specific application; or the enhanced interactive app with social features. The total follow-up duration is 18 months. Primary endpoint is the cost utility of using app-based therapeutic intervention; secondary endpoints are: compliance with treatment guidelines, app use (professionals and patients), patients' satisfaction, budget impact analysis.
The findings will inform the deployment and reimbursement of the application. The study has ethical approval by the Ile de France ethics committee. Dissemination of the results will be presented at conferences and in peer-reviewed publications.
NCT03090828.
终末期肾病（ESRD）影响法国约 84000 人，估计成本为 42 亿欧元。对患者进行疾病教育可以赋予其能力，改善其疾病管理，提高健康结果。本研究旨在探讨向患者教育中添加互动式网络平台是否有效且具有成本效益，此外，通过社交功能和特性来补充该平台是否可以提高其性能。
将严重的 ESRD 或移植后患者随机分为 1:1:1 组，分别接受标准治疗教育；或使用特定应用程序进行教育；或使用具有社交功能的增强型互动应用程序进行教育。总的随访时间为 18 个月。主要终点是使用基于应用程序的治疗干预的成本效用；次要终点是：治疗指南的遵守情况、应用程序使用（专业人员和患者）、患者满意度、预算影响分析。
研究结果将为应用程序的部署和报销提供信息。该研究已获得法兰西岛伦理委员会的伦理批准。研究结果将在会议和同行评议出版物中进行呈现。
NCT03090828。
