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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
600
Telesurveillance and therapeutic support
CHU Caen
Caen, France
CHU Chalon
Chalon-sur-Saône, France
CHU Clermont Ferrand
Clermont-Ferrand, France
Centre hospitalier Saint Joseph Saint Luc
Lyon, France
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
Time frame: Data collection all along the study: 3 years
Evaluation of costs related to each strategy
All medical expenses will be collected in the case report form
Time frame: Data collection every 4 months at least, all along the study: 3 years
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)
Time frame: every 4 months, all along the study: 3 years
Evaluation of the financial impact of NeLLY service implementation in France
All medical expenses will be collected in the case report form
Time frame: Data collection every 4 months at least, all along the study: 3 years
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.
Time frame: Data collection all along the study: 3 years
Evaluation of NeLLY service impacts on dialysis and transplant
The question is: does NeLLY delay resorting to dialysis, avoid emergency dialysis, encourage transplant
Time frame: Data collection all along the study: 3 years
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CHU Marseille
Marseille, France
CHU Reims
Reims, France
CHU Rennes
Rennes, France
ARTIC 42
Saint-Etienne, France
CHU Saint Etienne
Saint-Etienne, France
CALYDIAL
Vienne, France
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.
Time frame: 4 times during the study: 3 years