The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients.

Frontiers in nephrology Pub Date : 2025-06-19 eCollection Date: 2025-01-01 DOI:10.3389/fneph.2025.1591962
Mario Schiffer, Lars Pape, Julia K Wolff, Raoul Gertges, Vanessa Visconti, Karen Reichert, Anja Pfau, Anne Dieterle, Katja Sauerstein, Andreas Kribben, Kristina Boss, Sinem Karaterzi, Felix Nensa, Philipp Winneckens, Mario Cypko, Wiebke Duettmann, Bianca Zukunft, Eva Schrezenmeier, Marcel G Naik, Fabian Halleck, Roland Roller, Sebastian Möller, Oliver Amft, Klemens Budde
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引用次数: 0

Abstract

Background: Regular follow-up care after kidney transplantation is performed in transplant centers together with local nephrologist practices in Germany. Patients after kidney transplantation have to fulfill many tasks and manage their disease, follow a complex therapeutic regimen, communicate with the transplant center and home nephrologists, and coordinate doctor appointments. It has been shown that mHealth solutions such as mobile phone applications (apps) can support patients in their self-management. However, stand-alone apps have limitations and ideally, the mHealth solutions are embedded in a holistic treatment approach, including healthcare professionals.

Methods: We will conduct a 1-year, prospective, randomized, 2-armed, parallel group multicenter trial in three German Kidney Transplant Centers (KTCs) to demonstrate that additional and continuous interventional telemedical management will improve health after kidney transplantation in patients of all ages. Therefore, a composite endpoint of seven key outcome variables [fewer hospitalizations, shorter length of hospitalization, less development of de novo donor-specific antibody (DSA), better medication adherence, lower tacrolimus intra-patient variability, better blood pressure control, and better renal function after kidney transplantation]was defined. All the patients will receive the same routine post-transplant aftercare. The patients in the interventional arm will receive additional predefined telemedical management, including regular telemedicine visits and automatic bidirectional data transfer (e.g., vital signs, wellbeing, medication plan, and laboratory data together with a chat option) between the patient at home and the KTC through a certified smartphone app. If necessary, a home nephrologist can be included in the automatic data transfer. In the interventional arm, the iBox score will be used to better detect patients at risk for early graft failure and drug-drug interactions will be regularly checked with certified software.

Discussion: The study aims to prolong patient and graft survival through additional telemedical services in order to reduce avoidable hospitalizations, improve treatment of co-morbidities, and improve adherence through patient empowerment, which should result in lower health care costs, and better quality of life of patients after kidney transplantation.

Clinical trial registration: ClinicalTrials.gov, identifier NCT05897047.

smartntx研究:一项前瞻性、随机对照试验,旨在调查肾移植受者额外介入远程医疗管理与标准术后护理的对比。
背景:在德国,肾移植后的定期随访护理是在移植中心与当地肾病专家一起进行的。肾移植后的患者必须完成许多任务和管理他们的疾病,遵循复杂的治疗方案,与移植中心和家庭肾病学家沟通,并协调医生预约。研究表明,移动医疗解决方案(如移动电话应用程序)可以支持患者进行自我管理。然而,独立的应用程序有局限性,理想情况下,移动医疗解决方案应嵌入整体治疗方法,包括医疗保健专业人员。方法:我们将在三个德国肾移植中心(ktc)进行一项为期1年的前瞻性、随机、双臂、平行组多中心试验,以证明额外和持续的介入远程医疗管理将改善所有年龄段患者肾移植后的健康状况。因此,定义了7个关键结局变量的复合终点[住院次数减少、住院时间缩短、新生供体特异性抗体(DSA)较少、更好的药物依从性、更低的他克莫司患者内变异性、更好的血压控制和肾移植后更好的肾功能]。所有患者将接受相同的移植后常规护理。介入组的患者将接受额外的预定义远程医疗管理,包括定期远程医疗访问,以及通过认证的智能手机应用程序在患者家中和KTC之间自动双向数据传输(例如,生命体征、健康状况、药物计划和实验室数据以及聊天选项)。如有必要,家庭肾病专家可以参与自动数据传输。在介入治疗方面,iBox评分将用于更好地检测有早期移植物衰竭风险的患者,药物-药物相互作用将通过认证软件定期检查。讨论:该研究旨在通过额外的远程医疗服务延长患者和移植物的生存期,以减少可避免的住院治疗,改善合并症的治疗,并通过患者赋权提高依从性,从而降低医疗成本,提高肾移植后患者的生活质量。临床试验注册:ClinicalTrials.gov,标识符NCT05897047。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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