The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients
BackgroundRegular 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 th...
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Frontiers Media S.A.
2025-06-01
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| author | Mario Schiffer Lars Pape Julia K. Wolff 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 Mario Cypko Wiebke Duettmann Bianca Zukunft Eva Schrezenmeier Marcel G. Naik Fabian Halleck Roland Roller Sebastian Möller Sebastian Möller Oliver Amft Oliver Amft Klemens Budde |
| author_facet | Mario Schiffer Lars Pape Julia K. Wolff 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 Mario Cypko Wiebke Duettmann Bianca Zukunft Eva Schrezenmeier Marcel G. Naik Fabian Halleck Roland Roller Sebastian Möller Sebastian Möller Oliver Amft Oliver Amft Klemens Budde |
| author_sort | Mario Schiffer |
| collection | DOAJ |
| description | BackgroundRegular 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.MethodsWe 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.DiscussionThe 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 RegistrationClinicalTrials.gov, identifier NCT05897047. |
| format | Article |
| id | doaj-art-7ec55b75aec44dd3a7dab16c404ea732 |
| institution | OA Journals |
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| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Nephrology |
| spelling | doaj-art-7ec55b75aec44dd3a7dab16c404ea7322025-08-20T02:07:51ZengFrontiers Media S.A.Frontiers in Nephrology2813-06262025-06-01510.3389/fneph.2025.15919621591962The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipientsMario Schiffer0Lars Pape1Julia K. Wolff2Julia K. Wolff3Raoul Gertges4Vanessa Visconti5Karen Reichert6Anja Pfau7Anne Dieterle8Katja Sauerstein9Andreas Kribben10Kristina Boss11Sinem Karaterzi12Felix Nensa13Philipp Winneckens14Mario Cypko15Mario Cypko16Wiebke Duettmann17Bianca Zukunft18Eva Schrezenmeier19Marcel G. Naik20Fabian Halleck21Roland Roller22Sebastian Möller23Sebastian Möller24Oliver Amft25Oliver Amft26Klemens Budde27Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, GermanyDepartment of Pediatrics II, University Hospital of Essen, University of Duisburg-Essen, Essen, GermanyInstitut für Gesundheits- und Sozialforschung (IGES) Institute, Berlin, GermanyDepartment of Prevention Research and Social Medicine, Institute for Community Medicine, University Medicine Greifswald, Greifswald, GermanyDepartment of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, GermanyDepartment of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, GermanyDepartment of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, GermanyDepartment of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, GermanyDepartment of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, GermanyDepartment of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, GermanyDepartment of Nephrology, University Hospital of Essen, University of Duisburg-Essen, Essen, GermanyDepartment of Nephrology, University Hospital of Essen, University of Duisburg-Essen, Essen, GermanyInstitute for Artificial Intelligence in Medicine (IKIM), University Hospital Essen, Essen, GermanyInstitute for Artificial Intelligence in Medicine (IKIM), University Hospital Essen, Essen, GermanyInstitute for Artificial Intelligence in Medicine (IKIM), University Hospital Essen, Essen, GermanyIntelligent Embedded Systems, University of Freiburg, Freiburg, GermanyHahn-Schickard, Freiburg, GermanyDepartment of Nephrology, Charité, Berlin, GermanyDepartment of Nephrology, Charité, Berlin, GermanyDepartment of Nephrology, Charité, Berlin, GermanyDepartment of Nephrology, Charité, Berlin, GermanyDepartment of Nephrology, Charité, Berlin, Germany0German Research Center for Artificial Intelligence (DFKI), Berlin, Germany0German Research Center for Artificial Intelligence (DFKI), Berlin, Germany1Technische Universität Berlin, Berlin, GermanyIntelligent Embedded Systems, University of Freiburg, Freiburg, GermanyHahn-Schickard, Freiburg, GermanyDepartment of Nephrology, Charité, Berlin, GermanyBackgroundRegular 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.MethodsWe 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.DiscussionThe 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 RegistrationClinicalTrials.gov, identifier NCT05897047.https://www.frontiersin.org/articles/10.3389/fneph.2025.1591962/fullkidney transplantationaftercarepatient empowermentAPPrandomized controlled trial (RCT) |
| spellingShingle | Mario Schiffer Lars Pape Julia K. Wolff 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 Mario Cypko Wiebke Duettmann Bianca Zukunft Eva Schrezenmeier Marcel G. Naik Fabian Halleck Roland Roller Sebastian Möller Sebastian Möller Oliver Amft Oliver Amft Klemens Budde The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients Frontiers in Nephrology kidney transplantation aftercare patient empowerment APP randomized controlled trial (RCT) |
| title | The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients |
| title_full | The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients |
| title_fullStr | The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients |
| title_full_unstemmed | The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients |
| title_short | The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients |
| title_sort | smartntx study a prospective randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipients |
| topic | kidney transplantation aftercare patient empowerment APP randomized controlled trial (RCT) |
| url | https://www.frontiersin.org/articles/10.3389/fneph.2025.1591962/full |
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