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| Name | Class |
|---|---|
| Hospices Civils de Lyon | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cluster 1 | Experimental | NeLLY service is implemented after 8 months. |
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| Cluster 2 | Experimental | NeLLY service is implemented after 12 months. |
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| Cluster 3 | Experimental | NeLLY service is implemented after 16 months. |
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| Cluster 4 | Experimental | NeLLY service is implemented after 20 months. |
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| Cluster 5 | Experimental | NeLLY service is implemented after 24 months. |
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| Cluster 6 | Experimental | NeLLY service is implemented after 28 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeLLY service | Device | Telesurveillance and therapeutic support |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CAILLETTE BEAUDOIN Agnès | Contact | 428873800 | +33 | direction@calydial.org |
| CAMARROQUE Anne-Laure | Contact | 428873851 | +33 | anne-laure.camarroque@calydial.org |
| Name | Affiliation | Role |
|---|---|---|
| CAILLETTE BEAUDOIN Agnès | Calydial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen | Caen | 14033 | France |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Multicentre study, in randomized mastered clusters, in stepped wedge
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| Cluster 7 | Experimental | NeLLY service is implemented after 32 months. |
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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 |
| CHU Chalon | Chalon-sur-Saône | 71100 | France |
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| CHU Clermont Ferrand | Clermont-Ferrand | 63000 | France |
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| Centre hospitalier Saint Joseph Saint Luc | Lyon | 60365 | France |
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| CHU Marseille | Marseille | 13005 | France |
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| CHU Reims | Reims | 51092 | France |
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| CHU Rennes | Rennes | 35033 | France |
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| ARTIC 42 | Saint-Etienne | 42270 | France |
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| CHU Saint Etienne | Saint-Etienne | 42270 | France |
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| CALYDIAL | Vienne | 38200 | France |
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| D052801 | Male Urogenital Diseases |