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

NCT ID: NCT03348839

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2021-06-30

Brief Summary

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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

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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).

Conditions

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Chronic Kidney Disease stage4 Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Multicentre study, in randomized mastered clusters, in stepped wedge
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

no one

Study Groups

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Cluster 1

NeLLY service is implemented after 8 months.

Group Type EXPERIMENTAL

NeLLY service

Intervention Type DEVICE

Telesurveillance and therapeutic support

Cluster 2

NeLLY service is implemented after 12 months.

Group Type EXPERIMENTAL

NeLLY service

Intervention Type DEVICE

Telesurveillance and therapeutic support

Cluster 3

NeLLY service is implemented after 16 months.

Group Type EXPERIMENTAL

NeLLY service

Intervention Type DEVICE

Telesurveillance and therapeutic support

Cluster 4

NeLLY service is implemented after 20 months.

Group Type EXPERIMENTAL

NeLLY service

Intervention Type DEVICE

Telesurveillance and therapeutic support

Cluster 5

NeLLY service is implemented after 24 months.

Group Type EXPERIMENTAL

NeLLY service

Intervention Type DEVICE

Telesurveillance and therapeutic support

Cluster 6

NeLLY service is implemented after 28 months.

Group Type EXPERIMENTAL

NeLLY service

Intervention Type DEVICE

Telesurveillance and therapeutic support

Cluster 7

NeLLY service is implemented after 32 months.

Group Type EXPERIMENTAL

NeLLY service

Intervention Type DEVICE

Telesurveillance and therapeutic support

Interventions

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NeLLY service

Telesurveillance and therapeutic support

Intervention Type DEVICE

Other Intervention Names

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Ap'Telecare

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role collaborator

Calydial

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CAILLETTE BEAUDOIN Agnès

Role: PRINCIPAL_INVESTIGATOR

Calydial

Locations

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CHU Caen

Caen, , France

Site Status

CHU Chalon

Chalon-sur-Saône, , France

Site Status

CHU Clermont Ferrand

Clermont-Ferrand, , France

Site Status

Centre hospitalier Saint Joseph Saint Luc

Lyon, , France

Site Status

CHU Marseille

Marseille, , France

Site Status

CHU Reims

Reims, , France

Site Status

CHU Rennes

Rennes, , France

Site Status

ARTIC 42

Saint-Etienne, , France

Site Status

CHU Saint Etienne

Saint-Etienne, , France

Site Status

CALYDIAL

Vienne, , France

Site Status

Countries

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France

Central Contacts

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CAILLETTE BEAUDOIN Agnès

Role: CONTACT

428873800 ext. +33

CAMARROQUE Anne-Laure

Role: CONTACT

428873851 ext. +33

Facility Contacts

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LOBBEDEZ Thierry

Role: primary

231272343 ext. +33

DUBOT Philippe

Role: primary

3 85 91 00 56 ext. +33

HENG Anne-Elisabeth

Role: primary

473751425 ext. +33

VILLAR Emmanuel

Role: primary

4 78 61 89 72 ext. +33

BRUNET Philippe

Role: primary

4 91 38 30 42 ext. +33

RIEU Philippe

Role: primary

3 26 78 76 38 ext. +33

VIGNEAU Cécile

Role: primary

2 99 28 94 90 ext. +33

BERTHOUX François

Role: primary

4 77 91 03 86 ext. +33

ALAMARTINE Eric

Role: primary

4 77 82 83 45 ext. +33

CAILLETTE BEAUDOIN Agnès

Role: primary

428873800 ext. +33

Other Identifiers

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PRME-16-0418

Identifier Type: -

Identifier Source: org_study_id

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