Chronic Kidney DiseaseseNephroNCT02082093

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

A study testing Telemedicine System in people with Chronic Kidney Diseases, run by Pharmagest Interactive at 8 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Diseases
What is being tested?: Telemedicine System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 635 participants
Where: 8 sitesFrance
Study dates: Nov 2015to 30 Jun 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

France8 sites

AURAD Aquitaine
Bordeaux
CHU Bordeaux
Bordeaux
CH Boulogne sur Mer
Boulogne-sur-Mer
TELECOM Bretagne
Brest
CH Dunkerque
Dunkirk
CHU Lille
Lille
ALTIR
Nancy
CHU Nancy
Nancy

Other trials in France

About this study

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.

Read the 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.

Conditions: Chronic Kidney Diseases
Being tested: Telemedicine System
Keywords: Chronic Kidney Disease, telemedicine
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telemedicine SystemDevice

Study groups in NCT02082093
Study group	Role	What they receive
Traditional Care	No intervention	Not described
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 Receives: Device: Telemedicine System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

Compliance
Girerd's auto questionnaire to assess compliance
Measured: Base Line, 6 months, One Year
Quality of Life of patients
Populations 1 and 2 : KDQoL questionnaire to assess quality of life Population 3 : Re TRANSQoL questionnaire
Measured: Base Line, One Year
Anxiety-Depression State
HAD Questionnaire
Measured: Base Line, One Year
Change in the glomerular filtration rate
Population 1 : One Year Change in the GFR estimated by MDRD equation (delta GFR/year)
Measured: Base Line, One Year
Anemia Control
the anemia control is assessed by the achievement of hemoglobin, ferritin and saturation coefficient Transferrin targets
Measured: One Year
Change in the glomerular filtration rate
Population 3 : One Year Change in the GFR estimated by MDRD equation (delta GFR/year)
Measured: Base Line, One Year
Consultations and Hospitalizations unplanned
Number of consultations and conventional hospitalizations unplanned in Transplantation center over a year
Measured: One Year
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.
Measured: One Year
Intervention's costs
Costs related to the evaluated intervention : Costs installation, equipment , training and maintenance of the telemedicine system
Measured: One Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201530 Jun 2019

First posted10 Mar 2014 (estimated)
Study startNov 2015
Primary completion30 Jun 2019
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 635 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02082093
Sponsor's protocol ID: eNephro
Acronym: eNephro
Status last verified: Sep 2019
First submitted: 14 Feb 2014
Last updated: 6 Sep 2019
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 28381266

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure
ClinicalTrials.gov ID: NCT02082093
Acronym / sponsor ID: eNephro / eNephro
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease, telemedicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 635 participants (actual)
Lead sponsor: Pharmagest InteractiveIndustry (pharma, biotech, devices)
Study start: Nov 2015 (actual)
Primary completion: 30 Jun 2019 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 10 Mar 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Traditional Care	No intervention	–
eNephro Application	Experimental	Device: Telemedicine SystemTelemedicine 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telemedicine System	Device	eNephro Application

Primary outcome

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

9 secondary outcomes

Compliance
Time frame: Base Line, 6 months, One Year
Quality of Life of patients
Time frame: Base Line, One Year
Anxiety-Depression State
Time frame: Base Line, One Year
Change in the glomerular filtration rate
Time frame: Base Line, One Year
Anemia Control
Time frame: One Year
Change in the glomerular filtration rate
Time frame: Base Line, One Year
Consultations and Hospitalizations unplanned
Time frame: One Year
Disease's Costs
Time frame: One Year
Intervention's costs
Time frame: One Year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
Derived from this study: PubMed 28381266Thilly 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.
Individual participant dataSharing planned: No

Related trials for Chronic Kidney Diseases

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michèle Kessler, Pr principal investigator

CHU Nancy, Nephrology Service

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine System in people with Chronic Kidney Diseases, run by Pharmagest Interactive at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined endpoint achievement of target blood pressure and proteinuria (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02082093, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.