Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to demonstrate the efficiency ( cost-effectiveness ) of a telemedicine system : eNephro Application , compared with traditional care in the management of chronic renal failure in different populations : population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria . population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay Two statistical analysis will be done : a main analysis for the one year initial follow-up for each patient a secondary analysis for the one year initial follow-up estended by one year (proposed to each patient at the end of the initial follow-up), that is a 2 years period. The intervention tested in this study is a telemedicine system which is a collaborative and expert system, consisting of: A dynamic shared medical record for the collection of administrative , medical, biological and clinical data for each patient. All health professionals can access the folder and fill in the support. It is the same for patients treated at home. A secure messaging for communication between health professionals and between patients and health professionals Expert systems analyzing data from each patient A management tool of therapeutic education Each patient and whatever the group will perform as part of its monitoring of the CKD assessments at baseline , 6 months, 12 months, 18 months (Populations 1 and 2) and end of study (24 months). These evaluations are about compliance, quality of life, anxiety - depression state. To enhance costs the point of view retained will be health insurance's point of view. Among the various costs, only direct costs are considered: disease management, hospitalizations, consultations in hospitals and private practice, prescribed medical transportation , home visits by health professionals, additional assessments related to the evaluated intervention. A probabilistic matching with the data bases of the National Information System of the Social Insurance will be performed. In addition, the acceptability of the system of telemedicine by patients in the intervention and health professionals will be also evaluated.

Detailed Description
-----------------
Three populations are recruited with the following inclusion criteria: age ≥ 18 years; ability to use a tablet device (alone or with assistance); population 1: stabilised stage 3B or stage 4 CKD with nephrology management of less than 3 years; population 2: stage 5D CKD treated by homecare peritoneal dialysis (PD) or out centre haemodialysis (HD); population 3: stage 5T CKD treated by renal transplantation for 3 to 12 months. Non-inclusion criteria are: dialysis after renal transplantation failure; organ transplantation other than kidney; life expectancy < 1 year.

Official Title
-----------------
Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure

Conditions
-----------------
Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Device: Telemedicine System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with CKD Stage 3B 4 ESRD patients receiving ambulatory dialysis , Patients treated with Renal Transplantation In CKD patients stage 3B 4: nephrology care ≤ 3 years, for transplant patients: Renal Transplantation ≥ 3 months but ≤ 12 months Patients can use an IT tool or having in their entourage one who knows how to use Exclusion Criteria: Acute Renal Failure at the time of inclusion Patient in transplant failure Patient with another organ transplant Patient whose life is at stake in the short term (Life expectancy <1 year)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional Care<br> | |
| Experimental: eNephro Application<br>Telemedicine system which is a collaborative and expert system, consisting of: A dynamic shared medical record for the collection of administrative , medical, biological and clinical data for each patient. All health professionals can access the folder and fill in the support. It is the same for patients treated at home. A secure messaging for communication between health professionals and between patients and health professionals Expert systems analyzing data from each patient A management tool of therapeutic education These patients have a chronic renal failure moderate to end up being treated by ambulatory dialysis or kidney transplantation. The patients of each population will be randomly assigned in group 1 ie traditional care or in group 2 ie traditional care added by telemedicine system | Device: Telemedicine System<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined endpoint achievement of target blood pressure and proteinuria | population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria | one year | 
| Cumulative duration of hospitalization in short-stay for 1 year | population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay for 1 year | one year | 
| Cumulative duration of unplanned short stay for 1 year | population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay for 1 year | One year | 
| Survival | Population 2 : Survival without events event = hospitalization whatever the duration and/or return to in-center dialysis | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance | Girerd's auto questionnaire to assess compliance | Base Line, 6 months, One Year | 
| Quality of Life of patients | Populations 1 and 2 : KDQoL questionnaire to assess quality of life Population 3 : Re TRANSQoL questionnaire | Base Line, One Year | 
| Anxiety-Depression State | HAD Questionnaire | Base Line, One Year | 
| Change in the glomerular filtration rate | Population 1 : One Year Change in the GFR estimated by MDRD equation (delta GFR/year) | Base Line, One Year | 
| Anemia Control | the anemia control is assessed by the achievement of hemoglobin, ferritin and saturation coefficient Transferrin targets | One Year | 
| Change in the glomerular filtration rate | Population 3 : One Year Change in the GFR estimated by MDRD equation (delta GFR/year) | Base Line, One Year | 
| Consultations and Hospitalizations unplanned | Number of consultations and conventional hospitalizations unplanned in Transplantation center over a year | One Year | 
| Disease's Costs | To enhance cost, the health insurance's point of a view is retained. Among the various costs, only direct costs are taken into account , there are : costs associated with the management of the disease hospitalizations' costs consultations ' costs (hospital and liberal sectors) prescribed medical transport's cost health professional costs additional tests costs. A probabilistic matching with the data bases of the National Information System of the Social Insurance will be performed. In addition, the acceptability of the system of telemedicine by patients in the intervention and health professionals will be also evaluated. | One Year | 
| Intervention's costs | Costs related to the evaluated intervention : Costs installation, equipment , training and maintenance of the telemedicine system | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, telemedicine