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

NCT02082093 | Completed DMC

• 1 other identifier: eNephro
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 8

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.

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease; telemedicine

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Survival

  Population 2 : Survival without events event = hospitalization whatever the duration and/or return to in-center dialysis

  One Year

Secondary Outcomes (9)

• Compliance

  Base Line, 6 months, One Year

• Quality of Life of patients

  Base Line, One Year

• Anxiety-Depression State

  Base Line, One Year

• Change in the glomerular filtration rate

  Base Line, One Year

• Anemia Control

  One Year

Other Outcomes (1)

• Acceptability

  One Year

Study Arms (2)

Traditional Care

NO INTERVENTION

eNephro Application

EXPERIMENTAL

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

Device: Telemedicine System

Interventions

Telemedicine System DEVICE

eNephro Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient in transplant failure
• Patient with another organ transplant
• Patient whose life is at stake in the short term (Life expectancy \<1 year)

Sponsors & Collaborators

• Pharmagest Interactive: lead

Study Sites (8)

AURAD Aquitaine

Bordeaux, France

Location

CHU Bordeaux

Bordeaux, France

Location

CH Boulogne sur Mer

Boulogne-sur-Mer, France

Location

TELECOM Bretagne

Brest, France

Location

CH Dunkerque

Dunkirk, France

Location

CHU Lille

Lille, France

Location

ALTIR

Nancy, France

Location

CHU Nancy

Nancy, France

Location

Related Publications (1)

• 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.

  PMID: 28381266 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michèle Kessler, Pr

  CHU Nancy, Nephrology Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: March 10, 2014
• Study Start: November 1, 2015
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (8)