Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-02 @ 5:24 AM
Study NCT ID:
NCT02082093
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2014-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure
Sponsor:
Pharmagest Interactive
Organization:
Study Overview
Official Title:
Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eNephro
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.
* 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: