Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

Study Overview
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Brief Summary
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Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.

Official Title
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Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

Conditions
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Renal Transplantation

Intervention / Treatment
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* Other: Ap'Telecare
* Other: traditional schedule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients transplanted for at least 3 months Stable renal graft function Exclusion Criteria: No home internet access Major disability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority Randomized Controlled Trial comparing Non-inferiority Randomized Controlled Trial comparing (i) a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) to (ii) a group of patients assisted by Ap'TELACARE and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: traditional patient follow-up<br>a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule (every other week up to 6 months post-transplant, once a month up to year 1, every three months up to year 2 and every 6 months thereafter) | Other: traditional schedule<br>* a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule<br>|
| Experimental: medically-tailored follow-up with Ap'Telecare<br>a group of patients assisted by Ap'Telecare and consulting their Transplant Centre following a less stringent schedule of consultations (every month up to 6 months, every other month up to year 1, every six months up to year 2 and once a year thereafter). | Other: Ap'Telecare<br>* an internet application on a computer, tablet or smartphone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients experiencing at least one episode of graft dysfunction | graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure of immunosuppressive treatment | Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic | 2 years | 
| number of patients who needed to return to dialysis |  | 2 years | 
| number of patients with acute or chronic transplant rejection |  | 2 years | 
| Post-transplant complication |  | 2 years | 
| Death |  | 2 years | 
| Quality of life assessed | EuroQol group - 5 Dimensions ( EQ-5D) scale | 2 years | 
| Level of anxiety and depression | Hospital Anxiety and Depression (HAD) scale | 2 years | 
| Incremental cost-effectiveness evaluation criteria | Cost per QALY earned (QALYs estimated from the EuroQol group - 5 Dimensions ( EQ-5D) quality of life scale). | 2 years | 
| Evaluation criteria for the Budget Impact Analysis | Average cost saved per 100 patients treated in the Ap'Telecare group compared to the traditional follow-up. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine