Clinical trial NCT02082093: Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure
Official title: Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease
telemedicine
Lead sponsor: Pharmagest Interactive
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 635
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Combined endpoint achievement of target blood pressure and proteinuria
timeFrame: one year
measure: Cumulative duration of hospitalization in short-stay for 1 year
timeFrame: one year
measure: Cumulative duration of unplanned short stay for 1 year
timeFrame: One year
measure: Survival
timeFrame: One Year
Secondary outcomes:
measure: Compliance
timeFrame: Base Line, 6 months, One Year
measure: Quality of Life of patients
timeFrame: Base Line, One Year
measure: Anxiety-Depression State
timeFrame: Base Line, One Year
measure: Change in the glomerular filtration rate
timeFrame: Base Line, One Year
measure: Anemia Control
timeFrame: One Year
measure: Change in the glomerular filtration rate
timeFrame: Base Line, One Year
measure: Consultations and Hospitalizations unplanned
timeFrame: One Year
measure: Disease's Costs
timeFrame: One Year
measure: Intervention's costs
timeFrame: One Year
Other outcomes:
measure: Acceptability
timeFrame: One Year
Locations:
city: Bordeaux
country: France
facility: AURAD Aquitaine
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Boulogne sur Mer
country: France
facility: CH Boulogne sur Mer
city: Brest
country: France
facility: TELECOM Bretagne
city: Dunkerque
country: France
facility: CH Dunkerque
city: Lille
country: France
facility: CHU Lille
city: Nancy
country: France
facility: ALTIR
city: Nancy
country: France
facility: CHU Nancy
Study officials:
affiliation: CHU Nancy, Nephrology Service
name: Michèle Kessler, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.