Chronic Kidney Disease stage4, Kidney Diseases
Conditions
Keywords
telemedicine, telemonitoring, educational therapy
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).
Interventions
DEVICENeLLY service
Telesurveillance and therapeutic support
Sponsors
Hospices Civils de Lyon
Calydial
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
no one
Intervention model description
Multicentre study, in randomized mastered clusters, in stepped wedge
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Countries
France
Contacts
Primary ContactCAILLETTE BEAUDOIN Agnès
Backup ContactCAMARROQUE Anne-Laure
Outcome results
None listed