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

Chronic Kidney Diseases Clinical Trial

— eNephro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082093
• Other study ID #: eNephro
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: Pharmagest Interactive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 635
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Device:
• Telemedicine System

Locations

Country	Name	City	State
France	AURAD Aquitaine	Bordeaux
France	CHU Bordeaux	Bordeaux
France	CH Boulogne sur Mer	Boulogne sur Mer
France	TELECOM Bretagne	Brest
France	CH Dunkerque	Dunkerque
France	CHU Lille	Lille
France	ALTIR	Nancy
France	CHU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Pharmagest Interactive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability	Acceptability questionnaire	One Year
Primary	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
Primary	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
Primary	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
Primary	Survival	Population 2 : Survival without events event = hospitalization whatever the duration and/or return to in-center dialysis	One Year
Secondary	Compliance	Girerd's auto questionnaire to assess compliance	Base Line, 6 months, One Year
Secondary	Quality of Life of patients	Populations 1 and 2 : KDQoL questionnaire to assess quality of life Population 3 : Re TRANSQoL questionnaire	Base Line, One Year
Secondary	Anxiety-Depression State	HAD Questionnaire	Base Line, One Year
Secondary	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
Secondary	Anemia Control	the anemia control is assessed by the achievement of hemoglobin, ferritin and saturation coefficient Transferrin targets	One Year
Secondary	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
Secondary	Consultations and Hospitalizations unplanned	Number of consultations and conventional hospitalizations unplanned in Transplantation center over a year	One Year
Secondary	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 : costs associated with the management of the disease; hospitalizations' costs; consultations ' costs (hospital and liberal sectors); prescribed medical transport's cost; health professional costs; additional tests costs. 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.	One Year
Secondary	Intervention's costs	Costs related to the evaluated intervention : Costs installation, equipment , training and maintenance of the telemedicine system	One Year