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

Pharmagest

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Device: Telemedicine System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02082093

eNephro

Details and patient eligibility

About

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.

Full 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.

Enrollment: 635 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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635 participants in 2 patient groups

Traditional Care

No Intervention group

eNephro Application

Experimental group

Description:

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

Treatment:

Device: Telemedicine System