Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease
- Conditions
- Kidney DiseasesChronic Kidney Disease stage4
- Interventions
- Device: NeLLY service
- Registration Number
- NCT03348839
- Lead Sponsor
- Calydial
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cluster 6 NeLLY service NeLLY service is implemented after 28 months. Cluster 7 NeLLY service NeLLY service is implemented after 32 months. Cluster 2 NeLLY service NeLLY service is implemented after 12 months. Cluster 1 NeLLY service NeLLY service is implemented after 8 months. Cluster 3 NeLLY service NeLLY service is implemented after 16 months. Cluster 4 NeLLY service NeLLY service is implemented after 20 months. Cluster 5 NeLLY service NeLLY service is implemented after 24 months.
- Primary Outcome Measures
Name Time Method Incremental cost-effectiveness ratio 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 Outcome Measures
Name Time Method Evaluation of costs related to each strategy 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 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 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 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 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 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.
Trial Locations
- Locations (10)
CHU Caen
🇫🇷Caen, France
CHU Chalon
🇫🇷Chalon-sur-Saône, France
CHU Clermont Ferrand
🇫🇷Clermont-Ferrand, France
CALYDIAL
🇫🇷Vienne, 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