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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NxStage Medical
ClinicalTrials.gov Identifier:
NCT00288613
First received: February 6, 2006
Last updated: July 22, 2014
Last verified: July 2014

February 6, 2006
July 22, 2014
January 2006
November 2013   (final data collection date for primary outcome measure)
Hospitalizations [ Time Frame: duration of study participation ] [ Designated as safety issue: Yes ]
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
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Complete list of historical versions of study NCT00288613 on ClinicalTrials.gov Archive Site
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FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Individuals with ESRD who are candidates for daily hemodialysis with the NxStage System One and have Medicare as the primary payor.

  • Kidney Failure, Chronic
  • End Stage Renal Disease, Requiring Dialysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
501
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00288613
CP0009
Yes
NxStage Medical
NxStage Medical
Not Provided
Principal Investigator: Bertrand L. Jaber, MD, FASN Unaffilated
NxStage Medical
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP