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)
NCT ID: NCT01615900
Last Updated: 2020-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
155 participants
INTERVENTIONAL
2012-02-07
2020-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Teleconsultation
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
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)
Interventions
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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 Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Locations
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Nantes University Hospital
Nantes, , France
Countries
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Other Identifiers
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BRD/11/06-O
Identifier Type: -
Identifier Source: org_study_id
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