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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 :
Two statistical analysis will be done :
The intervention tested in this study is a telemedicine system which is a collaborative and expert system, consisting of:
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.
Three populations are recruited with the following inclusion criteria:
Non-inclusion criteria are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional Care | No Intervention | ||
| eNephro Application | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine System | Device |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Acceptability questionnaire | One Year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michèle Kessler, Pr | CHU Nancy, Nephrology Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AURAD Aquitaine | Bordeaux | France | ||||
| CHU Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28381266 | Derived | Thilly N, Chanliau J, Frimat L, Combe C, Merville P, Chauveau P, Bataille P, Azar R, Laplaud D, Noel C, Kessler M. Cost-effectiveness of home telemonitoring in chronic kidney disease patients at different stages by a pragmatic randomized controlled trial (eNephro): rationale and study design. BMC Nephrol. 2017 Apr 5;18(1):126. doi: 10.1186/s12882-017-0529-2. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 :
| One Year |
| Intervention's costs | Costs related to the evaluated intervention : Costs installation, equipment , training and maintenance of the telemedicine system | One Year |
| Bordeaux |
| France |
| CH Boulogne sur Mer | Boulogne-sur-Mer | France |
| TELECOM Bretagne | Brest | France |
| CH Dunkerque | Dunkirk | France |
| CHU Lille | Lille | France |
| ALTIR | Nancy | France |
| CHU Nancy | Nancy | France |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |