FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
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| ClinicalTrials.gov Identifier: NCT00288613 |
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Recruitment Status :
Completed
First Posted : February 8, 2006
Last Update Posted : July 24, 2014
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Sponsor:
NxStage Medical
Information provided by (Responsible Party):
NxStage Medical
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Brief Summary:
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.
| Condition or disease |
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| Kidney Failure, Chronic End Stage Renal Disease, Requiring Dialysis |
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.
| Study Type : | Observational |
| Actual Enrollment : | 501 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | November 2013 |
| Actual Study Completion Date : | November 2013 |
Primary Outcome Measures :
- Hospitalizations [ Time Frame: 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Individuals with ESRD who are candidates for daily hemodialysis with the NxStage System One and have Medicare as the primary payor.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00288613
Locations
Show 41 study locations
Sponsors and Collaborators
NxStage Medical
Investigators
| Principal Investigator: | Bertrand L. Jaber, MD, FASN | Unaffilated |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | NxStage Medical |
| ClinicalTrials.gov Identifier: | NCT00288613 |
| Other Study ID Numbers: |
CP0009 |
| First Posted: | February 8, 2006 Key Record Dates |
| Last Update Posted: | July 24, 2014 |
| Last Verified: | July 2014 |
Keywords provided by NxStage Medical:
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ESRD Daily Hemodialysis Hemodialysis Kidney Failure Kidney Disease |
Additional relevant MeSH terms:
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Kidney Failure, Chronic Renal Insufficiency Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic |