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) (TELEGRAFT)

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.

Study Overview

• Status: Completed
• Conditions: Renal Transplant Patient
• Intervention / Treatment: Other: Teleconsultation / Standard consultation

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Teleconsultation	Other: Teleconsultation / Standard consultation; 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)
Other: Standard consultation	Other: Teleconsultation / Standard consultation; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2012
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 7, 2012
• First Posted (Estimate): June 11, 2012

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Teleconsultation; Renal graft; Kidney transplant failure score
• Other Study ID Numbers: BRD/11/06-O