Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 635
- 试验地点
- 10
- 主要终点
- Combined endpoint achievement of target blood pressure and proteinuria
研究概览
简要总结
The main objective of this study is to demonstrate the efficiency ( cost-effectiveness ) of a telemedicine system : eNephro Application , compared with traditional care in the management of chronic renal failure in different populations :
- population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria .
- population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay
- population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay
Two statistical analysis will be done :
- a main analysis for the one year initial follow-up for each patient
- a secondary analysis for the one year initial follow-up estended by one year (proposed to each patient at the end of the initial follow-up), that is a 2 years period.
The intervention tested in this study is a telemedicine system which is a collaborative and expert system, consisting of:
- A dynamic shared medical record for the collection of administrative , medical, biological and clinical data for each patient. All health professionals can access the folder and fill in the support. It is the same for patients treated at home.
- A secure messaging for communication between health professionals and between patients and health professionals
- Expert systems analyzing data from each patient
- A management tool of therapeutic education
Each patient and whatever the group will perform as part of its monitoring of the CKD assessments at baseline , 6 months, 12 months, 18 months (Populations 1 and 2) and end of study (24 months). These evaluations are about compliance, quality of life, anxiety - depression state. To enhance costs the point of view retained will be health insurance's point of view. Among the various costs, only direct costs are considered: disease management, hospitalizations, consultations in hospitals and private practice, prescribed medical transportation , home visits by health professionals, additional assessments related to the evaluated intervention. A probabilistic matching with the data bases of the National Information System of the Social Insurance will be performed. In addition, the acceptability of the system of telemedicine by patients in the intervention and health professionals will be also evaluated.
详细描述
Three populations are recruited with the following inclusion criteria:
- age ≥ 18 years;
- ability to use a tablet device (alone or with assistance);
- population 1: stabilised stage 3B or stage 4 CKD with nephrology management of less than 3 years;
- population 2: stage 5D CKD treated by homecare peritoneal dialysis (PD) or out centre haemodialysis (HD);
- population 3: stage 5T CKD treated by renal transplantation for 3 to 12 months.
Non-inclusion criteria are:
- dialysis after renal transplantation failure;
- organ transplantation other than kidney;
- life expectancy < 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with CKD Stage 3B 4 ESRD patients receiving ambulatory dialysis , Patients treated with Renal Transplantation
- •In CKD patients stage 3B 4: nephrology care ≤ 3 years, for transplant patients: Renal Transplantation ≥ 3 months but ≤ 12 months
- •Patients can use an IT tool or having in their entourage one who knows how to use
排除标准
- •Acute Renal Failure at the time of inclusion
- •Patient in transplant failure
- •Patient with another organ transplant
- •Patient whose life is at stake in the short term (Life expectancy <1 year)
结局指标
主要结局
Combined endpoint achievement of target blood pressure and proteinuria
时间窗: one year
population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria
Cumulative duration of hospitalization in short-stay for 1 year
时间窗: one year
population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay for 1 year
Survival
时间窗: One Year
Population 2 : Survival without events event = hospitalization whatever the duration and/or return to in-center dialysis
Cumulative duration of unplanned short stay for 1 year
时间窗: One year
population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay for 1 year
次要结局
- Anemia Control(One Year)
- Intervention's costs(One Year)
- Quality of Life of patients(Base Line, One Year)
- Anxiety-Depression State(Base Line, One Year)
- Compliance(Base Line, 6 months, One Year)
- Consultations and Hospitalizations unplanned(One Year)
- Disease's Costs(One Year)
- Change in the glomerular filtration rate(Base Line, One Year)