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Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease

Primary Purpose

Chronic Kidney Disease stage4, Kidney Diseases

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NeLLY service
Sponsored by
Calydial
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Disease stage4 focused on measuring telemedicine, telemonitoring, educational therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient with chronic kidney disease stage 4
  • patient with at least 1 cardiovascular comorbidity and / or diabetes
  • patient with internet connexion from home
  • patient having given his express consent

Exclusion Criteria:

  • dialysed patient
  • refusal of patient to take part in the research
  • impairment of vital prognosis within a short period
  • patient expecting a transplant from a living donor within 6 months

Sites / Locations

  • CHU Caen
  • CHU Chalon
  • CHU Clermont Ferrand
  • Centre hospitalier Saint Joseph Saint Luc
  • CHU Marseille
  • CHU Reims
  • CHU Rennes
  • ARTIC 42
  • CHU Saint Etienne
  • CALYDIAL

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cluster 1

Cluster 2

Cluster 3

Cluster 4

Cluster 5

Cluster 6

Cluster 7

Arm Description

NeLLY service is implemented after 8 months.

NeLLY service is implemented after 12 months.

NeLLY service is implemented after 16 months.

NeLLY service is implemented after 20 months.

NeLLY service is implemented after 24 months.

NeLLY service is implemented after 28 months.

NeLLY service is implemented after 32 months.

Outcomes

Primary Outcome Measures

Incremental cost-effectiveness ratio
The primary endpoint of the study is incremental cost-effectiveness ratio comparing 2 strategies : usual patients follow-up and NeLLY service

Secondary Outcome Measures

Evaluation of costs related to each strategy
All medical expenses will be collected in the case report form
Evaluation of quality of life related to each strategy
Specific questionnaire analysing patient's mobility, autonomy, pain and discomfort, anxiety and depression (patient's answer can be yes or no)
Evaluation of the financial impact of NeLLY service implementation in France
All medical expenses will be collected in the case report form
Evaluation of clinical impact of NeLLY service
The question is: does NeLLY reduce hospitalisation, slow chronic kidney disease evolution, increase blood pressure control. Data will be collected during usual nephrology consultations.
Evaluation of NeLLY service impacts on dialysis and transplant
The question is: does NeLLY delay resorting to dialysis, avoid emergency dialysis, encourage transplant
Evaluation of NeLLY service impacts on compliance of patients
Specific questionnaire: Did the patient forget this morning to take medication? Since his last consultation, did the patient already miss any medication at home? Is the patient sometimes late to take medication? Did the patient already forget medication because of a lapse of memory? Did the patient already miss to take a medication because the patient think it can do more harm than good? Do the patient believe having too many medication to take? Patient's answer can be yes or no.

Full Information

First Posted
November 14, 2017
Last Updated
January 16, 2018
Sponsor
Calydial
Collaborators
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03348839
Brief Title
Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease
Official Title
Multicentre Trial, With Stepped Wedge Randomized Controled Clusters, on Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Calydial
Collaborators
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This medico-economic research project (PRME) aim to analyse NeLLY service efficiency for not on dialysis severe chronic kidney disease (DFG < 30ml/mn) patients care. NeLLY is a service that includes telemonitoring, educational therapy and support for patients with severe chronic kidney disease.
Detailed Description
NeLLY study is a multicentre trial, with stepped wedge randomized controled clusters. 2 strategies will be compared: usual patients follow-up and NeLLY service. The primary endpoint of the study is incremental cost-effectiveness ratio. This 3 years study will include 600 French patients. NeLLY service, offering telemonitoring, educational therapy and support to patients with severe chronic kidney disease, is based on an app, both for patients and health professionals, named Ap'Telecare (@TMM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage4, Kidney Diseases
Keywords
telemedicine, telemonitoring, educational therapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Multicentre study, in randomized mastered clusters, in stepped wedge
Masking
None (Open Label)
Masking Description
no one
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cluster 1
Arm Type
Experimental
Arm Description
NeLLY service is implemented after 8 months.
Arm Title
Cluster 2
Arm Type
Experimental
Arm Description
NeLLY service is implemented after 12 months.
Arm Title
Cluster 3
Arm Type
Experimental
Arm Description
NeLLY service is implemented after 16 months.
Arm Title
Cluster 4
Arm Type
Experimental
Arm Description
NeLLY service is implemented after 20 months.
Arm Title
Cluster 5
Arm Type
Experimental
Arm Description
NeLLY service is implemented after 24 months.
Arm Title
Cluster 6
Arm Type
Experimental
Arm Description
NeLLY service is implemented after 28 months.
Arm Title
Cluster 7
Arm Type
Experimental
Arm Description
NeLLY service is implemented after 32 months.
Intervention Type
Device
Intervention Name(s)
NeLLY service
Other Intervention Name(s)
Ap'Telecare
Intervention Description
Telesurveillance and therapeutic support
Primary Outcome Measure Information:
Title
Incremental cost-effectiveness ratio
Description
The primary endpoint of the study is incremental cost-effectiveness ratio comparing 2 strategies : usual patients follow-up and NeLLY service
Time Frame
Data collection all along the study: 3 years
Secondary Outcome Measure Information:
Title
Evaluation of costs related to each strategy
Description
All medical expenses will be collected in the case report form
Time Frame
Data collection every 4 months at least, all along the study: 3 years
Title
Evaluation of quality of life related to each strategy
Description
Specific questionnaire analysing patient's mobility, autonomy, pain and discomfort, anxiety and depression (patient's answer can be yes or no)
Time Frame
every 4 months, all along the study: 3 years
Title
Evaluation of the financial impact of NeLLY service implementation in France
Description
All medical expenses will be collected in the case report form
Time Frame
Data collection every 4 months at least, all along the study: 3 years
Title
Evaluation of clinical impact of NeLLY service
Description
The question is: does NeLLY reduce hospitalisation, slow chronic kidney disease evolution, increase blood pressure control. Data will be collected during usual nephrology consultations.
Time Frame
Data collection all along the study: 3 years
Title
Evaluation of NeLLY service impacts on dialysis and transplant
Description
The question is: does NeLLY delay resorting to dialysis, avoid emergency dialysis, encourage transplant
Time Frame
Data collection all along the study: 3 years
Title
Evaluation of NeLLY service impacts on compliance of patients
Description
Specific questionnaire: Did the patient forget this morning to take medication? Since his last consultation, did the patient already miss any medication at home? Is the patient sometimes late to take medication? Did the patient already forget medication because of a lapse of memory? Did the patient already miss to take a medication because the patient think it can do more harm than good? Do the patient believe having too many medication to take? Patient's answer can be yes or no.
Time Frame
4 times during the study: 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patient with chronic kidney disease stage 4 patient with at least 1 cardiovascular comorbidity and / or diabetes patient with internet connexion from home patient having given his express consent Exclusion Criteria: dialysed patient refusal of patient to take part in the research impairment of vital prognosis within a short period patient expecting a transplant from a living donor within 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CAILLETTE BEAUDOIN Agnès
Phone
428873800
Ext
+33
Email
direction@calydial.org
First Name & Middle Initial & Last Name or Official Title & Degree
CAMARROQUE Anne-Laure
Phone
428873851
Ext
+33
Email
anne-laure.camarroque@calydial.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAILLETTE BEAUDOIN Agnès
Organizational Affiliation
Calydial
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LOBBEDEZ Thierry
Phone
231272343
Ext
+33
Facility Name
CHU Chalon
City
Chalon-sur-Saône
ZIP/Postal Code
71100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DUBOT Philippe
Phone
3 85 91 00 56
Ext
+33
Facility Name
CHU Clermont Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HENG Anne-Elisabeth
Phone
473751425
Ext
+33
Facility Name
Centre hospitalier Saint Joseph Saint Luc
City
Lyon
ZIP/Postal Code
60365
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VILLAR Emmanuel
Phone
4 78 61 89 72
Ext
+33
Facility Name
CHU Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BRUNET Philippe
Phone
4 91 38 30 42
Ext
+33
Facility Name
CHU Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
RIEU Philippe
Phone
3 26 78 76 38
Ext
+33
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VIGNEAU Cécile
Phone
2 99 28 94 90
Ext
+33
Facility Name
ARTIC 42
City
Saint-Étienne
ZIP/Postal Code
42270
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BERTHOUX François
Phone
4 77 91 03 86
Ext
+33
Facility Name
CHU Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42270
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALAMARTINE Eric
Phone
4 77 82 83 45
Ext
+33
Facility Name
CALYDIAL
City
Vienne
ZIP/Postal Code
38200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CAILLETTE BEAUDOIN Agnès
Phone
428873800
Ext
+33
Email
direction@calydial.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease

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