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

Mario Schiffer^1*Lars Pape²Julia K Wolff³Raoul Gertges¹Vanessa Visconti²Karen Reichert¹Anja Pfau¹Anne Dieterle¹Katja Sauerstein¹Andreas Kribben²Kristina Boss²Sinem Karaterzi²Felix Nensa²Philipp Winneckens²Mario Cypko^4,5Wiebke Duettmann⁶Bianca Zukunft⁶Eva Schrezenmeier⁶Marcel G. Naik⁶Fabian Halleck⁶Roland Roller⁷Sebastian Möller⁷Oliver Amft^4,5Klemens Budde⁶

• ¹University Hospital Erlangen, Erlangen, Germany
• ²Essen University Hospital, Essen, North Rhine-Westphalia, Germany
• ³IGES Institute GmbH, Berlin, Baden-Württemberg, Germany
• ⁴Hahn-Schickard-Gesellschaft für angewandte Forschung, Villingen-Schwenningen, Germany
• ⁵Intelligent Embedded Systems Lab, Albert-Ludwigs-Universität Freiburg, Freiburg, Germany
• ⁶Charité University Medicine Berlin, Berlin, Baden-Wurttemberg, Germany
• ⁷German Research Center for Artificial Intelligence (DFKI), Kaiserslautern, Rheinland-Pfalz, Germany

Regular follow-up care after kidney transplantation is performed in transplant centers together with local nephrologist's 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 like 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.We 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 patients receive the same routine post-transplant aftercare. Patients in the interventional arm will receive additional predefined telemedical management including regular telemedicine visits and automatic bidirectional data transfer (e.g. vital signs, well-being, medication plan, laboratory data together with chat option) between the patient at home and the KTC through a certified smartphone App. If possible, 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.The study aims to prolong patient and graft survival through additional telemedical services in order to reduce avoidable hospitalizations, improve treatment of comorbidities and improve adherence through patient empowerment, which should result in lower health care costs, and better quality of life of patients after kidney transplantation.