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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:Any
Updated:9/23/2012
Start Date:January 2006

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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.

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
We found this trial at
40
sites
545 Barnhill Dr
Indianapolis, Indiana 46201
(317) 274-8157
Indiana University Medical Center Indiana University Health is Indiana
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Alma, Michigan 48801
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Brighton, Massachusetts 02135
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Charleston, South Carolina 29414
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Chattanooga, Tennessee 37421
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Cherry Hill, New Jersey 07675
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Chicago, Illinois 60607
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Denver, Colorado 80262
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Fort Smith, Arkansas 72901
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Frontenac, Missouri 63131
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Garden Grove, California 92843
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Glen Ellyn, Illinois 60137
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Greenfield, Wisconsin 53220
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Hampton, Virginia 23666
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Hot Springs, Arkansas 71901
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Lincoln, Nebraska 66510
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Louisville, Kentucky 40202
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Mishawaka, Indiana 46545
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Mountain View, California 94041
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New Haven, Connecticut 06511
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Niagara Falls, New York 14304
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Omaha, Nebraska 68198
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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San Antonio, Texas 78224
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Sandy Springs, Georgia 30350
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Saratoga Springs, New York 12866
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Seattle, Washington 98122
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Simi Valley, California 93065
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Springfield, Ohio 45505
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Topeka, Kansas 66606
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Traverse City, Michigan 49684
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Westwood, New Jersey 07675
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Winston-Salem, North Carolina 27157
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Wyoming, Michigan 49509
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York, Pennsylvania 15198
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