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临床试验/NCT03750331
NCT03750331进行中(未招募)不适用

Impact of the Use of Remote Monitoring in the Follow-up of the Renal Transplant Patient.

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 738 人开始时间: 2018年12月17日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
738
试验地点
2
主要终点
Patients experiencing at least one episode of graft dysfunction

研究概览

简要总结

Transplant Centers are facing new organisational challenges with regards to the growing number of patients they have to follow-up. We have developed and assessed the feasibility of using a novel web application permitting a medically-tailored follow-up of stable renal transplanted outpatients: Ap'TELECARE. This novel approach is likely to facilitate the organization of patients' follow-up at the Transplant Centre level as well as to provide secondary individual benefits in terms of therapeutic education, adherence to treatment and eventually to improve long term outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Patients transplanted for at least 3 months
  • Stable renal graft function

排除标准

  • No home internet access
  • Major disability

结局指标

主要结局

Patients experiencing at least one episode of graft dysfunction

时间窗: 2 years

graft dysfunction defined by a drop of at least 20% of their usual estimated Glomerular Filtration Rate (eGFR) value)

次要结局

  • Quality of life assessed(2 years)
  • Level of anxiety and depression(2 years)
  • Post-transplant complication(2 years)
  • Death(2 years)
  • Evaluation criteria for the Budget Impact Analysis(2 years)
  • Failure of immunosuppressive treatment(2 years)
  • number of patients who needed to return to dialysis(2 years)
  • number of patients with acute or chronic transplant rejection(2 years)
  • Incremental cost-effectiveness evaluation criteria(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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