Randomized Open Label Study Evaluating the Coverage by Teleconsultation Versus Standard Follow-up of Renal Transplant Patients According to a Risk Score of Early Graft Failure (KTFS)

Study Overview
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Brief Summary
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The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations.

Official Title
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Randomized Open Label Study Evaluating the Coverage by Teleconsultation Versus Standard Follow-up of Renal Transplant Patients According to a Risk Score of Early Graft Failure (KTFS)

Conditions
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Renal Transplant Patient

Intervention / Treatment
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* Other: Teleconsultation / Standard consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient Having received a deceased donor renal transplant one year ago Having an access internet high-speed Having a compatible computer and supporting the videoconference Calculable KTFS (Kidney Transplant Failure Score) Patient having participated in a therapeutic educational program Patient has given informed consent Patient insured Exclusion Criteria: Patient under age 18 Patient having received a multi-organ transplant (heart kidney / liver kidney / kidney pancreas / lung kidney / heart lung kidney) Patient non-compliant BK virus nephropathy or BK positive viremia CMV positive viremia Identified and treated psychiatric disorders Participation in another clinical study Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Teleconsultation<br> | Other: Teleconsultation / Standard consultation<br>* Stage 1: randomization. Two arms: teleconsultation and standard consultation Stage 2: calculation of Kidney Transplant Failure Score which will determine 4 sub-groups: teleconsultation high risk, teleconsultation low risk, standard consultation high risk and standard consultation low risk. Stage 3: follow-up (2 years) according to the group: Standard consultation low risk: consultation every 2 months during one year and then every 3 months during one year Standard consultation high risk: consultation every 6 weeks during one year and then every 2 months during one year Teleconsultation low risk: same follow-up as standard consultation low risk group but all the consultations are teleconsultations Teleconsultation high risk: same follow-up as standard consultation high risk group but the follow-up will be intensified by the addition of an intermediate teleconsultation (between 2 consultations)<br>|
| Other: Standard consultation<br> | Other: Teleconsultation / Standard consultation<br>* Stage 1: randomization. Two arms: teleconsultation and standard consultation Stage 2: calculation of Kidney Transplant Failure Score which will determine 4 sub-groups: teleconsultation high risk, teleconsultation low risk, standard consultation high risk and standard consultation low risk. Stage 3: follow-up (2 years) according to the group: Standard consultation low risk: consultation every 2 months during one year and then every 3 months during one year Standard consultation high risk: consultation every 6 weeks during one year and then every 2 months during one year Teleconsultation low risk: same follow-up as standard consultation low risk group but all the consultations are teleconsultations Teleconsultation high risk: same follow-up as standard consultation high risk group but the follow-up will be intensified by the addition of an intermediate teleconsultation (between 2 consultations)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events | The main objective of this study is to optimize the coverage of renal transplant patients thanks to a personalized follow-up based on a risk score of early graft failure (KTFS, Kidney Transplant Failure Score), associated with teleconsultations. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of the personalized follow-up |  | 2 years | 
| Quality of life linked to the health of transplant patients |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal graft, Teleconsultation, Kidney transplant failure score