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 June 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01615900
First received: June 7, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Renal Transplant Patient
Other: Teleconsultation / Standard consultation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Number of serious adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • Cost-effectiveness of the personalized follow-up [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of life linked to the health of transplant patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: February 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01615900

Contacts
Contact: Aurélie MEURETTE, Dr +33 2 40 08 74 35 aurelie.meurette@chu-nantes.fr

Locations
France
Lyon University Hospital Not yet recruiting
Lyon, France
Contact: Emmanuel MORELON, Pr    +33 4 72 11 01 78    emmanuel.morelon@chu-lyon.fr   
Principal Investigator: Emmanuel MORELON, Pr         
Montpellier University Hospital Not yet recruiting
Montpellier, France
Contact: Georges MOURAD, Pr    +33 4 67 33 84 76    g-mourad@chu-montpellier.fr   
Principal Investigator: Georges MOURAD, Pr         
Nantes University Hospital Recruiting
Nantes, France
Contact: Aurélie MEURETTE, Dr    +33 2 40 08 74 35    aurelie.meurette@chu-nantes.fr   
Principal Investigator: Aurélie MEURETTE, Dr         
Necker Hospital / AP-HP Not yet recruiting
Paris, France
Contact: Christophe LEGENDRE, Dr    +33 1 44 49 53 55    Christophe.legendre@nck.ap-hop_paris.fr   
Principal Investigator: Christophe LEGENDRE, Pr         
Toulouse University Hospital Not yet recruiting
Toulouse, France
Contact: Lionel ROSTAING, Pr    +33 5 61 32 25 84    rostaing.l@chu-toulouse.fr   
Principal Investigator: Lionel ROSTAING, Pr         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01615900     History of Changes
Other Study ID Numbers: 11/6-O
Study First Received: June 7, 2012
Last Updated: June 7, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Renal graft
Teleconsultation
Kidney transplant failure score

ClinicalTrials.gov processed this record on April 23, 2014