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

NCT02082093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 635

Last updated 2019-09-06

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Diseases

Interventions

DEVICE

Telemedicine System

Sponsors & Collaborators

  • Pharmagest Interactive

    lead INDUSTRY

Principal Investigators

  • Michèle Kessler, Pr · CHU Nancy, Nephrology Service

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02082093 on ClinicalTrials.gov