TELEGRAFT 2015.
| Trial name or 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 |
| Methods | Phase 4, open level, randomised, multicentric and prospective study Randomised to novel eHealth program versus standard care 1:1 randomisation, stratified by centres and performed at 1 year post kidney transplant with patient participation planned for 2 years |
| Participants | 1 year post kidney transplant, access to high speed internet, without ongoing CMV or BKV infection, men and non‐pregnant women, without mental disorders and provide informed consent |
| Interventions | eHealth intervention: provided with a USB which allows collection of medication information before video conferencing. USB opens a secure internet connection via an intuitive interface specifically designed for non‐internet specialist patients. Also provided with tablet computer (e.g. iPad) devoted for video conferencing. Low risk patients will be interviewed 3 times with VC with pulse, weight, temperature and BP collected on USB, with only 1 in‐person complete checkup conducted per year. For high risk patients they will have in person 1 complete check up and 5 standard visits + 6 additional VCs to reinforce follow‐up. Standard care: patients classified as low risk of graft failure within first 8 years post‐transplantation will be scheduled 4 visits at the hospital per year, whilst high risk patients will be scheduled 6 visits. Standard visits include clinical examination of BP, weight, blood and urine monitoring and 1 visit encompassing a complete checkup of further biochemistry, morphologic exams and questionnaires related to QoL and psychological dimensions. |
| Outcomes | Primary outcome is composite and defined by absence of major complications until 2 years post randomisation (e.g. patient alive with functioning kidney, without acute rejection episodes, without decrease in eGFR higher than 25% and without cancer. Secondary outcomes: to evaluate efficiency of system ‐ incremental cost‐effectiveness ratios, transplant specific QoL, evolution of psychological dimensions related to stress and coping, anxiety/depression |
| Starting date | February 2012 |
| Contact information | aurelie.meurette@chu‐nantes.fr |
| Notes | clinical trials updated May 2016 ‐ recruitment ongoing, estimated completion date September 2020 |