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临床试验/NCT00288613
NCT00288613已完成不适用

FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study

NxStage Medical37 个研究点 分布在 1 个国家目标入组 501 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
501
试验地点
37
主要终点
Hospitalizations

研究概览

简要总结

Purpose The purpose of this study is to compare the economical impact and clinical parameters of short daily hemodialysis using the NxStage® System One hemodialysis device with thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data System (USRDS) database.

详细描述

In the 21st century, nephrologists in the United States face many challenges including a forecast of decline in physician manpower. Challenges that are specific to hemodialysis (HD) include reimbursement constraints, a growing shortage of nurses and major technological advances in dialysis equipment. There is a growing interest in alternative dialysis regimen and frequency, but a lack of patient incentive for self-care dialysis either in the center or in the home setting. The proposed phase 4 post-marketing study plans to explore whether daily HD is economically attractive compared with thrice weekly HD, while improving health-related quality of life and other dialysis adequacy measures. This project is unique as it provides a large prospective cohort of patients converted to daily HD, with a longitudinal follow up and an ability to compare to a matched cohort from the United States Renal Data Services. This study will help develop whether daily dialysis is economically attractive through the use of new technologies that reduce treatment costs and decrease hospitalization rates, with the long-term hope of increasing life expectancy. All patients will have the option to participate in the Quotidian Dialysis Registry, coordinated by the Lawson Health Research Institute (LHRI) in London, Ontario.

研究设计

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

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

  • Diagnosis of ESRD and require dialysis
  • Medicare as primary payor (NOTE: Does not include Medicare HMO as primary payer)
  • Candidate for daily hemodialysis (defined as 6 or more times per week)
  • Ability to understand and willingness to sign an informed consent statement and a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement

排除标准

  • Current use of the NxStage System One hemodialysis device
  • Previous enrollment in this study
  • Current enrollment in another investigational drug or device trial which might impact the outcome measures planned in this study
  • Likelihood of not surviving the training period

结局指标

主要结局

Hospitalizations

时间窗: duration of study participation

To compare the all-cause hospitalizations reported in days per patient year on daily hemodialysis using NxStage System One hemodialysis device to thrice-weekly conventional in-center dialysis using a matched cohort from the US Renal Data System (USRDS) database

次要结局

未报告次要终点

研究者

发起方
NxStage Medical
申办方类型
Other
责任方
Sponsor

研究点 (37)

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