Multicentre Trial, With Stepped Wedge Randomized Controled Clusters, on Medico-economic Impacts of NeLLY Service for Not on Dialysis Severe Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 发起方
- Calydial
- 入组人数
- 600
- 试验地点
- 20
- 主要终点
- Incremental cost-effectiveness ratio
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
no one
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cluster 1
NeLLY service is implemented after 8 months.
干预措施: NeLLY service (Device)
Cluster 2
NeLLY service is implemented after 12 months.
干预措施: NeLLY service (Device)
Cluster 3
NeLLY service is implemented after 16 months.
干预措施: NeLLY service (Device)
Cluster 4
NeLLY service is implemented after 20 months.
干预措施: NeLLY service (Device)
Cluster 5
NeLLY service is implemented after 24 months.
干预措施: NeLLY service (Device)
Cluster 6
NeLLY service is implemented after 28 months.
干预措施: NeLLY service (Device)
Cluster 7
NeLLY service is implemented after 32 months.
干预措施: NeLLY service (Device)
结局指标
主要结局
Incremental cost-effectiveness ratio
时间窗: 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
次要结局
- Evaluation of costs related to each strategy(Data collection every 4 months at least, all along the study: 3 years)
- Evaluation of quality of life related to each strategy(every 4 months, all along the study: 3 years)
- Evaluation of the financial impact of NeLLY service implementation in France(Data collection every 4 months at least, all along the study: 3 years)
- Evaluation of clinical impact of NeLLY service(Data collection all along the study: 3 years)
- Evaluation of NeLLY service impacts on dialysis and transplant(Data collection all along the study: 3 years)
- Evaluation of NeLLY service impacts on compliance of patients(4 times during the study: 3 years)