AzTrials
AzTrials

Chronic Kidney Disease stage4NCT03348839

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

A study testing NeLLY service in people with Chronic Kidney Disease stage4 and Kidney Diseases, run by Calydial at 10 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
NeLLY service
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
10 sitesFrance
Study dates
Mar 2018to Jun 2021
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

CAILLETTE BEAUDOIN Agnès contact

428873800 ext. +33

direction@calydial.org

CAMARROQUE Anne-Laure contact

428873851 ext. +33

anne-laure.camarroque@calydial.org

10 sites in 1 country

France10 sites

  • CHU Caen

    Caen, 14033

    LOBBEDEZ Thierry, 231272343 ext. +33

  • CHU Chalon

    Chalon-sur-Saône, 71100

    DUBOT Philippe, 3 85 91 00 56 ext. +33

  • CHU Clermont Ferrand

    Clermont-Ferrand, 63000

    HENG Anne-Elisabeth, 473751425 ext. +33

  • Centre hospitalier Saint Joseph Saint Luc

    Lyon, 60365

    VILLAR Emmanuel, 4 78 61 89 72 ext. +33

  • CHU Marseille

    Marseille, 13005

    BRUNET Philippe, 4 91 38 30 42 ext. +33

  • CHU Reims

    Reims, 51092

    RIEU Philippe, 3 26 78 76 38 ext. +33

  • CHU Rennes

    Rennes, 35033

    VIGNEAU Cécile, 2 99 28 94 90 ext. +33

  • ARTIC 42

    Saint-Etienne, 42270

    BERTHOUX François, 4 77 91 03 86 ext. +33

  • CHU Saint Etienne

    Saint-Etienne, 42270

    ALAMARTINE Eric, 4 77 82 83 45 ext. +33

  • CALYDIAL

    Vienne, 38200

    CAILLETTE BEAUDOIN Agnès, 428873800 ext. +33, direction@calydial.org

Other trials in France

About this study

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

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.

Read the 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).

Being tested
NeLLY service
Keywords
telemedicine, telemonitoring, educational therapy
Medical subject headings
Kidney Diseases

What participants receive

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

  • NeLLY serviceDevice

    Also called Ap'Telecare

    Telesurveillance and therapeutic support

Study groups in NCT03348839
Study groupRoleWhat they receive
Cluster 1ExperimentalNeLLY service is implemented after 8 months.
Receives: Device: NeLLY service
Cluster 2ExperimentalNeLLY service is implemented after 12 months.
Receives: Device: NeLLY service
Cluster 3ExperimentalNeLLY service is implemented after 16 months.
Receives: Device: NeLLY service
Cluster 4ExperimentalNeLLY service is implemented after 20 months.
Receives: Device: NeLLY service
Cluster 5ExperimentalNeLLY service is implemented after 24 months.
Receives: Device: NeLLY service
Cluster 6ExperimentalNeLLY service is implemented after 28 months.
Receives: Device: NeLLY service
Cluster 7ExperimentalNeLLY service is implemented after 32 months.
Receives: Device: NeLLY service

What is being measured

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

  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

    Measured: Data collection all along the study: 3 years

Secondary outcomes (6)

  1. Evaluation of costs related to each strategy

    All medical expenses will be collected in the case report form

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

  2. 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)

    Measured: every 4 months, all along the study: 3 years

  3. Evaluation of the financial impact of NeLLY service implementation in France

    All medical expenses will be collected in the case report form

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

  4. 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.

    Measured: Data collection all along the study: 3 years

  5. Evaluation of NeLLY service impacts on dialysis and transplant

    The question is: does NeLLY delay resorting to dialysis, avoid emergency dialysis, encourage transplant

    Measured: Data collection all along the study: 3 years

  6. 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.

    Measured: 4 times during the study: 3 years

Timeline

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

  1. First posted21 Nov 2017
  2. Study startMar 2018 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionJun 2021 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Multicentre study, in randomized mastered clusters, in stepped wedge
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03348839
Sponsor's protocol ID
PRME-16-0418
Status last verified
Nov 2017
First submitted
14 Nov 2017
Last updated
18 Jan 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NeLLY service in people with Chronic Kidney Disease stage4 and Kidney Diseases, run by Calydial at 10 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 4 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: status not confirmed, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

Results are not available in the source record.

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

Contact CAILLETTE BEAUDOIN Agnès (428873800 ext. +33, direction@calydial.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incremental cost-effectiveness ratio (time frame: Data collection all along the study: 3 years). 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 NCT03348839.

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 18 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in