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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) (TELEGRAFT)

This study is currently recruiting participants.
Verified November 2017 by Nantes University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615900
First Posted: June 11, 2012
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
June 7, 2012
June 11, 2012
November 21, 2017
February 7, 2012
June 2020   (Final data collection date for primary outcome measure)
Number of serious adverse events [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01615900 on ClinicalTrials.gov Archive Site
  • Cost-effectiveness of the personalized follow-up [ Time Frame: 2 years ]
  • Quality of life linked to the health of transplant patients [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
 
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)
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)
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Renal Transplant Patient
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)
  • Teleconsultation
    Intervention: Other: Teleconsultation / Standard consultation
  • Standard consultation
    Intervention: Other: Teleconsultation / Standard consultation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
September 2020
June 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Aurélie MEURETTE, Dr +33 2 40 08 74 35 aurelie.meurette@chu-nantes.fr
France
 
 
NCT01615900
BRD/11/06-O
Yes
Not Provided
Not Provided
Nantes University Hospital
Nantes University Hospital
Not Provided
Not Provided
Nantes University Hospital
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP