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

Calydial

Status: Unknown

Conditions: Kidney Diseases; Chronic Kidney Disease stage4

Treatments: Device: NeLLY service

Study type: Interventional

Funder types: Other

Identifiers

NCT03348839

PRME-16-0418

Details and patient eligibility

About

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 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).

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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600 participants in 7 patient groups

Cluster 1

Experimental group

Description:

NeLLY service is implemented after 8 months.

Treatment:

Device: NeLLY service

Cluster 2

Experimental group

Description:

NeLLY service is implemented after 12 months.

Treatment:

Device: NeLLY service

Cluster 3

Experimental group

Description:

NeLLY service is implemented after 16 months.

Treatment:

Device: NeLLY service

Cluster 4

Experimental group

Description:

NeLLY service is implemented after 20 months.

Treatment:

Device: NeLLY service

Cluster 5

Experimental group

Description:

NeLLY service is implemented after 24 months.

Treatment:

Device: NeLLY service

Cluster 6

Experimental group

Description:

NeLLY service is implemented after 28 months.

Treatment:

Device: NeLLY service

Cluster 7

Experimental group

Description:

NeLLY service is implemented after 32 months.

Treatment:

Device: NeLLY service