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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014