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

BMC Nephrology

Magali Giral⁶  Philippe Tessier³  Emmanuel Morélon¹  Christophe Legendre²  Sandra Gaboriau⁵  Emmanuelle Papuchon⁵  Karine Neau³  Sabrina Chailan³  Jean-Benoît Hardouin³  Angélique Bonnaud-Antignac⁴  Pascal Daguin⁵  Aurélie Meurette⁵  Yohann Foucher³ 

[1] Service de Néphrologie, Transplantation et Immunologie Clinique, Hôpital Edouard Herriot, Lyon, France;Service de Transplantation Rénale et de Soins Intensifs, Hôpital Necker, APHP and Universités Paris Descartes et Sorbonne Paris Cité, Paris, France;Délégation à la recherche clinique et à l'innovation, CHU Nantes, Nantes, France;SPHERE (EA4275) - Biostatistics, Clinical Research and Pharmaco-Epidemiology, Nantes University, Nantes, France;Institut de Transplantation et de Recherche en Transplantation, ITUN, CHU Nantes, Nantes University Hospital, 30, Boulevard Jean Monnet, Nantes 44035, France;CENTAURE Fondation, Centre d’Investigation Clinique en Biothérapie, Nantes University and INSERM U1064, Nantes, France

关键词: Randomized clinical trial;    Video conferencing;    Personalized follow-up;    Kidney transplantation;   

Others  :  1128642
DOI  :  10.1186/1471-2369-16-6

 received in 2014-12-17, accepted in 2015-01-14,  发布年份 2015

【 摘 要 】

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/design

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.

Discussion

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.

【 授权许可】

   
2015 Foucher et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

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