Pape L, de Zwaan M, Tegtbur U, Feldhaus F, Wolff J K, Schiffer L, Lerch C, Hellrung N, Kliem V, Lonnemann G, Nolting H D, Schiffer M
Department of Pediatric Kidney, Liver and Metabolic Diseases, Hannover Medical School, Carl-Neuberg-Straße 1, D-30625, Hannover, Germany.
Department of Psychosomatic Medicine and Psychotherapy, Hannover Medical School, Hannover, Germany.
BMC Health Serv Res. 2017 Aug 23;17(1):587. doi: 10.1186/s12913-017-2545-0.
Follow-up care after kidney transplantation is performed in transplant centers as well as in local nephrologist's practices in Germany. However, organized integrated care of these different sectors of the German health care system is missing. This organizational deficit as well as non-adherence of kidney recipients and longterm cardiovascular complications are major reasons for an impaired patient and graft survival.
The KTx360° study is supported by a grant from the Federal Joint Committee of the Federal Republic of Germany. The study will include 448 (39 children) incident patients of all ages with KTx after study start in May 2017 and 963 (83 children) prevalent patients with KTx between 2010 and 2016. The collaboration between transplant centers and nephrologists in private local practices will be supported by internet-based case-files and scheduled virtual visits (patient consultation via video conferencing). At specified points of the care process patients will receive cardiovascular and adherence assessments and respective interventions. Care will be coordinated by an additional case management. The goals of the study will be evaluated by an independent institute using claims data from the statutory health insurances and data collected from patients and their caregivers during study participation. To model longitudinal changes after transplantation and differences in changes and levels of immunosuppresive therapy after transplantation between study participants and historical data as well as data from control patients who do not participate in KTx360°, adjusted regression analyses, such as mixed models with repeated measures, will be used. Relevant confounders will be controlled in all analyses.
The study aims to prolong patient and graft survival, to reduce avoidable hospitalizations, co-morbidities and health care costs, and to enhance quality of life of patients after kidney transplantation.
ISRCTN29416382 (retrospectively registered on 05.05.2017).
在德国，肾移植后的随访护理在移植中心以及当地肾病科医生的诊所进行。然而，德国医疗保健系统中这些不同部门之间缺乏有组织的综合护理。这种组织上的缺陷以及肾移植受者的不依从性和长期心血管并发症是导致患者和移植物存活率受损的主要原因。
KTx360°研究由德意志联邦共和国联邦联合委员会提供资助。该研究将纳入2017年5月研究开始后所有年龄段的448例（39例儿童）新发肾移植患者，以及2010年至2016年间的963例（83例儿童）肾移植现患患者。移植中心与当地私人诊所的肾病科医生之间的合作将通过基于互联网的病例档案和定期虚拟访视（通过视频会议进行患者咨询）来支持。在护理过程的特定时间点，患者将接受心血管和依从性评估以及相应的干预措施。护理将通过额外的病例管理进行协调。该研究的目标将由一个独立机构使用法定医疗保险的理赔数据以及在研究参与期间从患者及其护理人员收集的数据进行评估。为了模拟移植后的纵向变化以及研究参与者与历史数据以及未参与KTx360°的对照患者之间移植后免疫抑制治疗变化和水平的差异，将使用调整后的回归分析，如具有重复测量的混合模型。在所有分析中都将控制相关混杂因素。
该研究旨在延长患者和移植物的存活期，减少可避免的住院、合并症和医疗保健成本，并提高肾移植后患者的生活质量。
ISRCTN29416382（于2017年5月5日追溯注册）。
