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)

Not Applicable

Completed

• Conditions: Renal Transplant Patient
• Interventions: Other: Teleconsultation / Standard consultation

• Registration Number: NCT01615900
• Lead Sponsor: Nantes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-07
• Study First Submitted: 2012-06-07
• Study First Submitted QC: 2012-06-07
• Study First Posted: 2012-06-11
• Status Verified: 2020-01
• Primary Completion: 2020-01-07
• Study Completion: 2020-01-07
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teleconsultation	Teleconsultation / Standard consultation	-
Standard consultation	Teleconsultation / Standard consultation	-

Primary Outcome Measures

Name	Time	Method
Number of serious adverse events	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness of the personalized follow-up	2 years
Quality of life linked to the health of transplant patients	2 years

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France