NCT03348839

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 18, 2018

Status Verified

November 1, 2017

Enrollment Period

3.3 years

First QC Date

November 14, 2017

Last Update Submit

January 16, 2018

Conditions

Chronic Kidney Disease stage4Kidney Diseases

Keywords

telemedicinetelemonitoringeducational therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    Data collection all along the study: 3 years

Secondary Outcomes (6)

  • Evaluation of costs related to each strategy

    Data collection every 4 months at least, all along the study: 3 years

  • Evaluation of quality of life related to each strategy

    every 4 months, all along the study: 3 years

  • Evaluation of the financial impact of NeLLY service implementation in France

    Data collection every 4 months at least, all along the study: 3 years

  • Evaluation of clinical impact of NeLLY service

    Data collection all along the study: 3 years

  • Evaluation of NeLLY service impacts on dialysis and transplant

    Data collection all along the study: 3 years

  • +1 more secondary outcomes

Study Arms (7)

Cluster 1

EXPERIMENTAL

NeLLY service is implemented after 8 months.

Device: NeLLY service

Cluster 2

EXPERIMENTAL

NeLLY service is implemented after 12 months.

Device: NeLLY service

Cluster 3

EXPERIMENTAL

NeLLY service is implemented after 16 months.

Device: NeLLY service

Cluster 4

EXPERIMENTAL

NeLLY service is implemented after 20 months.

Device: NeLLY service

Cluster 5

EXPERIMENTAL

NeLLY service is implemented after 24 months.

Device: NeLLY service

Cluster 6

EXPERIMENTAL

NeLLY service is implemented after 28 months.

Device: NeLLY service

Cluster 7

EXPERIMENTAL

NeLLY service is implemented after 32 months.

Device: NeLLY service

Interventions

NeLLY serviceDEVICE

Telesurveillance and therapeutic support

Also known as: Ap'Telecare
Cluster 1Cluster 2Cluster 3Cluster 4Cluster 5Cluster 6Cluster 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Caen

Caen, 14033, France

Location

CHU Chalon

Chalon-sur-Saône, 71100, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, 63000, France

Location

Centre hospitalier Saint Joseph Saint Luc

Lyon, 60365, France

Location

CHU Marseille

Marseille, 13005, France

Location

CHU Reims

Reims, 51092, France

Location

CHU Rennes

Rennes, 35033, France

Location

ARTIC 42

Saint-Etienne, 42270, France

Location

CHU Saint Etienne

Saint-Etienne, 42270, France

Location

CALYDIAL

Vienne, 38200, France

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • CAILLETTE BEAUDOIN Agnès

    Calydial

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CAILLETTE BEAUDOIN Agnès

CONTACT

428873800direction@calydial.org

CAMARROQUE Anne-Laure

CONTACT

428873851anne-laure.camarroque@calydial.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no one
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Multicentre study, in randomized mastered clusters, in stepped wedge
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 21, 2017

Study Start

March 1, 2018

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 18, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)