Renal Transplantation
Conditions
Keywords
telemedicine
Brief summary
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.
Interventions
OTHERAp'Telecare
an internet application on a computer, tablet or smartphone
OTHERtraditional schedule
a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule
Sponsors
Ministry of Health, France
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients transplanted for at least 3 months * Stable renal graft function
Exclusion criteria
* No home internet access * Major disability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients experiencing at least one episode of graft dysfunction | 2 years | graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Failure of immunosuppressive treatment | 2 years | Detection of donor-specific anti-HLA (Human Leukocyte Antigen) antibodies by LUMINEX technic |
| Level of anxiety and depression | 2 years | Hospital Anxiety and Depression (HAD) scale |
| Incremental cost-effectiveness evaluation criteria | 2 years | Cost per QALY earned (QALYs estimated from the EuroQol group - 5 Dimensions ( EQ-5D) quality of life scale). |
| Evaluation criteria for the Budget Impact Analysis | 2 years | Average cost saved per 100 patients treated in the Ap'Telecare group compared to the traditional follow-up. |
| Quality of life assessed | 2 years | EuroQol group - 5 Dimensions ( EQ-5D) scale |
Countries
France
Outcome results
None listed