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

January 16, 2018 updated by: Calydial

Multicentre Trial, With Stepped Wedge Randomized Controled Clusters, on Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14033
        • CHU Caen
      • Chalon-sur-Saône, France, 71100
        • CHU Chalon
      • Clermont-Ferrand, France, 63000
        • CHU Clermont Ferrand
      • Lyon, France, 60365
        • Centre Hospitalier Saint Joseph Saint Luc
      • Marseille, France, 13005
        • CHU Marseille
      • Reims, France, 51092
        • CHU Reims
      • Rennes, France, 35033
        • Chu Rennes
      • Saint-Étienne, France, 42270
        • ARTIC 42
      • Saint-Étienne, France, 42270
        • CHU Saint Etienne
      • Vienne, France, 38200
        • CALYDIAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cluster 1
NeLLY service is implemented after 8 months.
Device: NeLLY service
Telesurveillance and therapeutic support
Other Names:
  • Ap'Telecare
Experimental: Cluster 2
NeLLY service is implemented after 12 months.
Device: NeLLY service
Telesurveillance and therapeutic support
Other Names:
  • Ap'Telecare
Experimental: Cluster 3
NeLLY service is implemented after 16 months.
Device: NeLLY service
Telesurveillance and therapeutic support
Other Names:
  • Ap'Telecare
Experimental: Cluster 4
NeLLY service is implemented after 20 months.
Device: NeLLY service
Telesurveillance and therapeutic support
Other Names:
  • Ap'Telecare
Experimental: Cluster 5
NeLLY service is implemented after 24 months.
Device: NeLLY service
Telesurveillance and therapeutic support
Other Names:
  • Ap'Telecare
Experimental: Cluster 6
NeLLY service is implemented after 28 months.
Device: NeLLY service
Telesurveillance and therapeutic support
Other Names:
  • Ap'Telecare
Experimental: Cluster 7
NeLLY service is implemented after 32 months.
Device: NeLLY service
Telesurveillance and therapeutic support
Other Names:
  • Ap'Telecare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incremental cost-effectiveness ratio
Time Frame: Data collection all along the study: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of costs related to each strategy
Time Frame: Data collection every 4 months at least, all along the study: 3 years
All medical expenses will be collected in the case report form
Data collection every 4 months at least, all along the study: 3 years
Evaluation of quality of life related to each strategy
Time Frame: every 4 months, all along the study: 3 years
Specific questionnaire analysing patient's mobility, autonomy, pain and discomfort, anxiety and depression (patient's answer can be yes or no)
every 4 months, all along the study: 3 years
Evaluation of the financial impact of NeLLY service implementation in France
Time Frame: Data collection every 4 months at least, all along the study: 3 years
All medical expenses will be collected in the case report form
Data collection every 4 months at least, all along the study: 3 years
Evaluation of clinical impact of NeLLY service
Time Frame: Data collection all along the study: 3 years
The question is: does NeLLY reduce hospitalisation, slow chronic kidney disease evolution, increase blood pressure control. Data will be collected during usual nephrology consultations.
Data collection all along the study: 3 years
Evaluation of NeLLY service impacts on dialysis and transplant
Time Frame: Data collection all along the study: 3 years
The question is: does NeLLY delay resorting to dialysis, avoid emergency dialysis, encourage transplant
Data collection all along the study: 3 years
Evaluation of NeLLY service impacts on compliance of patients
Time Frame: 4 times during the study: 3 years

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.
4 times during the study: 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calydial

Collaborators

Hospices Civils de Lyon

Investigators

  • Principal Investigator: CAILLETTE BEAUDOIN Agnès, CALYDIAL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 16, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRME-16-0418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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