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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

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).

Interventions

  • Device: NeLLY service
    • Telesurveillance and therapeutic support

Arms, Groups and Cohorts

  • Experimental: Cluster 1
    • NeLLY service is implemented after 8 months.
  • Experimental: Cluster 2
    • NeLLY service is implemented after 12 months.
  • Experimental: Cluster 3
    • NeLLY service is implemented after 16 months.
  • Experimental: Cluster 4
    • NeLLY service is implemented after 20 months.
  • Experimental: Cluster 5
    • NeLLY service is implemented after 24 months.
  • Experimental: Cluster 6
    • NeLLY service is implemented after 28 months.
  • Experimental: Cluster 7
    • NeLLY service is implemented after 32 months.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • 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)
  • 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
  • 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.
  • 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
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Calydial
  • Collaborator
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • CAILLETTE BEAUDOIN Agnès, Principal Investigator, Calydial
  • Overall Contact(s)
    • CAILLETTE BEAUDOIN Agnès, 428873800, direction@calydial.org

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