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Trial record 1 of 1 for:    NCT02082093
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Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure (eNephro)

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ClinicalTrials.gov Identifier: NCT02082093
Recruitment Status : Active, not recruiting
First Posted : March 10, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmagest Interactive

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Device: Telemedicine System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 635 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure
Actual Study Start Date : November 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Traditional Care
Experimental: eNephro Application

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



Primary Outcome Measures :
  1. Combined endpoint achievement of target blood pressure and proteinuria [ Time Frame: one year ]
    population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria

  2. Cumulative duration of hospitalization in short-stay for 1 year [ Time Frame: one year ]
    population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay for 1 year

  3. Cumulative duration of unplanned short stay for 1 year [ Time Frame: One year ]
    population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay for 1 year

  4. Survival [ Time Frame: One Year ]
    Population 2 : Survival without events event = hospitalization whatever the duration and/or return to in-center dialysis


Secondary Outcome Measures :
  1. Compliance [ Time Frame: Base Line, 6 months, One Year ]
    Girerd's auto questionnaire to assess compliance

  2. Quality of Life of patients [ Time Frame: Base Line, One Year ]
    Populations 1 and 2 : KDQoL questionnaire to assess quality of life Population 3 : Re TRANSQoL questionnaire

  3. Anxiety-Depression State [ Time Frame: Base Line, One Year ]
    HAD Questionnaire

  4. Change in the glomerular filtration rate [ Time Frame: Base Line, One Year ]
    Population 1 : One Year Change in the GFR estimated by MDRD equation (delta GFR/year)

  5. Anemia Control [ Time Frame: One Year ]
    the anemia control is assessed by the achievement of hemoglobin, ferritin and saturation coefficient Transferrin targets

  6. Change in the glomerular filtration rate [ Time Frame: Base Line, One Year ]
    Population 3 : One Year Change in the GFR estimated by MDRD equation (delta GFR/year)

  7. Consultations and Hospitalizations unplanned [ Time Frame: One Year ]
    Number of consultations and conventional hospitalizations unplanned in Transplantation center over a year

  8. Disease's Costs [ Time Frame: One Year ]

    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.

  9. Intervention's costs [ Time Frame: One Year ]
    Costs related to the evaluated intervention : Costs installation, equipment , training and maintenance of the telemedicine system


Other Outcome Measures:
  1. Acceptability [ Time Frame: One Year ]
    Acceptability questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082093


Locations
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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, France
Sponsors and Collaborators
Pharmagest Interactive
Investigators
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Principal Investigator: Michèle Kessler, Pr CHU Nancy, Nephrology Service

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pharmagest Interactive
ClinicalTrials.gov Identifier: NCT02082093     History of Changes
Other Study ID Numbers: eNephro
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Pharmagest Interactive:
Chronic Kidney Disease
telemedicine

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases