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NCT Number: NCT02082093

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AURAD Aquitaine, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Telemedicine System

Device

Primary outcomes

  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 outcomes

  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 outcomes

  1. Acceptability

    Time frame: One Year

    Acceptability questionnaire

Sponsors and collaborators

Lead sponsor

Pharmagest Interactive

Industry

Registry information

Acronym: eNephro

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2014
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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