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临床试验/NCT01630824
NCT01630824Unknown不适用

Development an Effects of a Structural Education Programm in Adult Kidney Transplant Recipients

University of Jena2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
试验地点
2
主要终点
transplant survival

研究概览

简要总结

Kidney transplantation is the treatment of choice for patients with end-stage renal disease. The purpose of this randomized and controlled study is to evaluate the efficacy of a structured education program for adult kidney transplant recipients. Patients are randomly assigned to an educational program or to a standard care control group. The education group receives 8 lessons (each 90 minutes, 1 lesson per day), starting 4 days after kidney transplantation. Kidney transplant survival, number of rejections, infectious complications, length of hospital stay, blood pressure, HbA1c, glomerular filtration rate, quality of life (QoL) and knowledge are measured in both groups after 6, 12 and 24 months. The investigators postulate that the education group will have superior outcomes compared to the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being over 18 years recently had a kidney transplantation able to speak, write and understand german willing to participate regular visits after kidney transplantation

排除标准

  • severe complications after recent kidney transplantation early loss of the kidney allograft severe allograft dysfunction

结局指标

主要结局

transplant survival

时间窗: 2 years

次要结局

  • number of rejections(2 years)
  • days at hospital(2 years)
  • blood pressure control(2 years)
  • number of infectious complications(2 years)
  • quality of life (QoL)(2 years)

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Schinkoethe

Dr. med. Claudia Schinkoethe

University of Jena

研究点 (2)

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