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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A00677-48 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| traditional patient follow-up | Active Comparator | 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) |
|
| medically-tailored follow-up with Ap'Telecare | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ap'Telecare | Other | an internet application on a computer, tablet or smartphone |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Mariat, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont-Ferrand, CHU Site Gabriel-Montpied | Clermont-Ferrand | France | ||||
| CHU Saint-Etienne |
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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).
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| traditional schedule | Other | a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule |
|
| 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 |
| Saint-Etienne |
| France |