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

Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03348839
• Other study ID #: PRME-16-0418
• Status: Not yet recruiting
• Phase: N/A
• First received: November 14, 2017
• Last updated: January 16, 2018
• Start date: March 2018
• Est. completion date: June 2021

Study information

• Verified date: November 2017
• Source: Calydial
• Contact: CAILLETTE BEAUDOIN Agnès
• Phone: 428873800
• Email: direction[@]calydial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease stage4
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• NeLLY service
Telesurveillance and therapeutic support

Locations

Country	Name	City	State
France	CHU Caen	Caen
France	CHU Chalon	Chalon-sur-Saône
France	CHU Clermont Ferrand	Clermont-Ferrand
France	Centre hospitalier Saint Joseph Saint Luc	Lyon
France	CHU Marseille	Marseille
France	CHU Reims	Reims
France	CHU Rennes	Rennes
France	ARTIC 42	Saint-Étienne
France	CHU Saint Etienne	Saint-Étienne
France	CALYDIAL	Vienne

Sponsors (2)

Lead Sponsor	Collaborator
Calydial	Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluation of costs related to each strategy	All medical expenses will be collected in the case report form	Data collection every 4 months at least, all along the study: 3 years
Secondary	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)	every 4 months, all along the study: 3 years
Secondary	Evaluation of the financial impact of NeLLY service implementation in France	All medical expenses will be collected in the case report form	Data collection every 4 months at least, all along the study: 3 years
Secondary	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.	Data collection all along the study: 3 years
Secondary	Evaluation of NeLLY service impacts on dialysis and transplant	The question is: does NeLLY delay resorting to dialysis, avoid emergency dialysis, encourage transplant	Data collection all along the study: 3 years
Secondary	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.	4 times during the study: 3 years