跳至主要内容
临床试验/NCT01742234
NCT01742234已完成不适用

Renal and Lung Living Donors Evaluation (RELIVE) Informed Consent Study

National Institute of Allergy and Infectious Diseases (NIAID)0 个研究点目标入组 624 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
624
主要终点
Questionnaire Score 3

研究概览

简要总结

An organ transplant is frequently the best option and, in some cases, the only option to save the lives of transplant recipients. Receiving an organ from a living donor eliminates the need to wait for a deceased donor, an option that many transplant recipients do not survive. However, donating an organ presents health concerns to the donor as well. This study will use surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It will also compare participants' answers across geographic, racial and socio-economic backgrounds.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Living donor of a kidney or lung

排除标准

  • Unable to give informed consent

结局指标

主要结局

Questionnaire Score 3

时间窗: Change from 1 week prior to donation and 3 months after donation

Understanding of medical and psychosocial consequences of organ donation on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."

Questionnaire Score 1

时间窗: Change from 1 week prior to donation and 3 months after donation

Feelings of pressure to donate an organ on a 4-point scale e.g.; "1: No pressure" to "4: A lot of pressure."

Questionnaire Score 2

时间窗: Change from 1 week prior to donation and 3 months after donation

Understanding of the donor screening process on a 4-point scale e.g.; "1: No understanding" to "4: Full understanding."

次要结局

  • Questionnaire Score Secondary Endpoint 1(Change from 1 week prior to donation and 3 months after donation)
  • Questionnaire Score Secondary Endpoint 3(Change from 1 week prior to donation and 3 months after donation)
  • Questionnaire Score Secondary Endpoint 2(Change from 1 week prior to donation and 3 months after donation)
  • Questionnaire Score Secondary Endpoint 4(Change from 1 week prior to donation and 3 months after donation)

研究者

申办方类型
Nih
责任方
Sponsor

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