Clinical trial NCT03348839: Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease stage4
Kidney Diseases
Keywords: telemedicine
telemonitoring
educational therapy
Lead sponsor: Calydial
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
First posted: 2017-11-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicentre study, in randomized mastered clusters, in stepped wedge
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incremental cost-effectiveness ratio
timeFrame: Data collection all along the study: 3 years
Secondary outcomes:
measure: Evaluation of costs related to each strategy
timeFrame: Data collection every 4 months at least, all along the study: 3 years
measure: Evaluation of quality of life related to each strategy
timeFrame: every 4 months, all along the study: 3 years
measure: Evaluation of the financial impact of NeLLY service implementation in France
timeFrame: Data collection every 4 months at least, all along the study: 3 years
measure: Evaluation of clinical impact of NeLLY service
timeFrame: Data collection all along the study: 3 years
measure: Evaluation of NeLLY service impacts on dialysis and transplant
timeFrame: Data collection all along the study: 3 years
measure: Evaluation of NeLLY service impacts on compliance of patients
timeFrame: 4 times during the study: 3 years
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
city: Chalon-sur-Saône
country: France
facility: CHU Chalon
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Lyon
country: France
facility: Centre hospitalier Saint Joseph Saint Luc
city: Marseille
country: France
facility: CHU Marseille
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes
city: Saint-Étienne
country: France
facility: ARTIC 42
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
city: Vienne
country: France
facility: CALYDIAL
Study officials:
affiliation: Calydial
name: CAILLETTE BEAUDOIN Agnès
role: PRINCIPAL_INVESTIGATOR
References: