title: A personalized follow-up of kidney transplant recipients using video conferencing based on a 1-year scoring system predictive of long term graft failure (TELEGRAFT study): protocol for a randomized controlled trial.
abstract: BACKGROUND
  Numerous well-established clinical parameters are taken into consideration for the follow-up adaptation of kidney transplant recipients, but there are important disparities between countries, centres and clinicians. Therefore, novel scoring systems have been developed, for instance the Kidney Transplant Failure Score (KTFS) which aims to stratify patients according to their risk of return to dialysis. We hypothesize that the efficiency of the follow-up after one year post-transplantation can be improved by adapting it to the risk of graft failure defined by the KTFS estimation.
  
  
  METHODS
  We propose a phase IV, open label, randomized, multicentric and prospective study. The study is registered with the Clinical Trials Registry NCT01615900. 250 patients will be allocated to one of two arms: the eHealth program versus the standard of care at hospital. In the standard group, patients classified at low-risk (KTFS ≤ 4.17) will be scheduled 4 visits at hospital per year, whilst high-risk patients will visit hospital 6 times. In the eHealth group, patients classified at low-risk will be interviewed 3 times by video conferencing and once at hospital, whilst 6 visits at hospital and 6 video conferencing will be scheduled for high-risk patients.
  
  
  CONCLUSIONS
  The current study allows to scientifically evaluate the etiologic impact of a novel eHealth program. This is important to clarify the possible contribution of telemedicine in the improvement of medical follow-up. The proposed design based on 4 different sub-groups can be interesting to evaluate other personalized medicine programs.
authors: SPHERE (EA4275) - Biostatistics, Clinical Research and Pharmaco-Epidemiology, Nantes University, Nantes, France. Yohann.Foucher@univ-nantes.fr.|Institut de Transplantation et de Recherche en Transplantation, ITUN, CHU Nantes, Nantes University Hospital, 30, Boulevard Jean Monnet, Nantes, 44035, France. Yohann.Foucher@univ-nantes.fr.|Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. Yohann.Foucher@univ-nantes.fr.
authors: Yohann
authors: Y
authors: Foucher
authors: Institut de Transplantation et de Recherche en Transplantation, ITUN, CHU Nantes, Nantes University Hospital, 30, Boulevard Jean Monnet, Nantes, 44035, France. aurelie.meurette@chu-nantes.fr.
authors: Aurélie
authors: A
authors: Meurette
authors: Institut de Transplantation et de Recherche en Transplantation, ITUN, CHU Nantes, Nantes University Hospital, 30, Boulevard Jean Monnet, Nantes, 44035, France. pascal.daguin@chu-nantes.fr.
authors: Pascal
authors: P
authors: Daguin
authors: SPHERE (EA4275) - Biostatistics, Clinical Research and Pharmaco-Epidemiology, Nantes University, Nantes, France. angelique.bonnaud@univ-nantes.fr.
authors: Angélique
authors: A
authors: Bonnaud-Antignac
authors: SPHERE (EA4275) - Biostatistics, Clinical Research and Pharmaco-Epidemiology, Nantes University, Nantes, France. jean-benoit.hardouin@univ-nantes.fr.|Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. jean-benoit.hardouin@univ-nantes.fr.
authors: Jean-Benoît
authors: JB
authors: Hardouin
authors: Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. Sabrina.CHAILAN@chu-nantes.fr.
authors: Sabrina
authors: S
authors: Chailan
authors: Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. Karine.NEAU@chu-nantes.fr.
authors: Karine
authors: K
authors: Neau
authors: Institut de Transplantation et de Recherche en Transplantation, ITUN, CHU Nantes, Nantes University Hospital, 30, Boulevard Jean Monnet, Nantes, 44035, France. emmanuelle.papuchon@chu-nantes.fr.
authors: Emmanuelle
authors: E
authors: Papuchon
authors: Institut de Transplantation et de Recherche en Transplantation, ITUN, CHU Nantes, Nantes University Hospital, 30, Boulevard Jean Monnet, Nantes, 44035, France. Sandra.GABORIAU@chu-nantes.fr.
authors: Sandra
authors: S
authors: Gaboriau
authors: Service de Transplantation Rénale et de Soins Intensifs, Hôpital Necker, APHP and Universités Paris Descartes et Sorbonne Paris Cité, Paris, France. christophe.legendre@nck.ap-hop-paris.fr.
authors: Christophe
authors: C
authors: Legendre
authors: Service de Néphrologie, Transplantation et Immunologie Clinique, Hôpital Edouard Herriot, Lyon, France. emmanuel.morelon@chu-lyon.fr.
authors: Emmanuel
authors: E
authors: Morélon
authors: SPHERE (EA4275) - Biostatistics, Clinical Research and Pharmaco-Epidemiology, Nantes University, Nantes, France. philippe.tessier@univ-nantes.fr.|Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France. philippe.tessier@univ-nantes.fr.
authors: Philippe
authors: P
authors: Tessier
authors: SPHERE (EA4275) - Biostatistics, Clinical Research and Pharmaco-Epidemiology, Nantes University, Nantes, France. magali.giral@chu-nantes.fr.|Institut de Transplantation et de Recherche en Transplantation, ITUN, CHU Nantes, Nantes University Hospital, 30, Boulevard Jean Monnet, Nantes, 44035, France. magali.giral@chu-nantes.fr.|CENTAURE Fondation, Centre d'Investigation Clinique en Biothérapie, Nantes University and INSERM U1064, Nantes, France. magali.giral@chu-nantes.fr.
authors: Magali
authors: M
authors: Giral
mesh_terms: D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000534:rehabilitation*; D008297:Male; D017216:Telemedicine / Q000379:methods*; D049269:Videoconferencing
chemical_list: D007166:Immunosuppressive Agents
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