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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Multicentre Trial, With Stepped Wedge Randomized Controled Clusters, on Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease

Conditions
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Chronic Kidney Disease stage4, Kidney Diseases

Intervention / Treatment
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* Device: NeLLY service


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Multicentre study, in randomized mastered clusters, in stepped wedge
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cluster 1<br>NeLLY service is implemented after 8 months. | Device: NeLLY service<br>* Telesurveillance and therapeutic support<br>* Other names: Ap'Telecare;|
| Experimental: Cluster 2<br>NeLLY service is implemented after 12 months. | Device: NeLLY service<br>* Telesurveillance and therapeutic support<br>* Other names: Ap'Telecare;|
| Experimental: Cluster 3<br>NeLLY service is implemented after 16 months. | Device: NeLLY service<br>* Telesurveillance and therapeutic support<br>* Other names: Ap'Telecare;|
| Experimental: Cluster 4<br>NeLLY service is implemented after 20 months. | Device: NeLLY service<br>* Telesurveillance and therapeutic support<br>* Other names: Ap'Telecare;|
| Experimental: Cluster 5<br>NeLLY service is implemented after 24 months. | Device: NeLLY service<br>* Telesurveillance and therapeutic support<br>* Other names: Ap'Telecare;|
| Experimental: Cluster 6<br>NeLLY service is implemented after 28 months. | Device: NeLLY service<br>* Telesurveillance and therapeutic support<br>* Other names: Ap'Telecare;|
| Experimental: Cluster 7<br>NeLLY service is implemented after 32 months. | Device: NeLLY service<br>* Telesurveillance and therapeutic support<br>* Other names: Ap'Telecare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemedicine, telemonitoring, educational therapy