FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
- Conditions
- End Stage Renal Disease, Requiring DialysisKidney Failure, Chronic
- Registration Number
- NCT00288613
- Lead Sponsor
- NxStage Medical
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 501
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospitalizations 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Chattanooga Kidney Center
🇺🇸Chattanooga, Tennessee, United States
Northwest Kidney Centers
🇺🇸Seattle, Washington, United States
Arkansas Nephrology Research Associates
🇺🇸Hot Springs, Arkansas, United States
Fort Smith Regional Dialysis Center
🇺🇸Fort Smith, Arkansas, United States
Satellite Healthcare/Wellbound
🇺🇸Mountain View, California, United States
Renal Advantage (RAI)
🇺🇸Hampton, Virginia, United States
Kidney Center, Inc.
🇺🇸Simi Valley, California, United States
Metabolism Associates - New Haven CAPD
🇺🇸New Haven, Connecticut, United States
Emory, Renal Care Partners of Dunwoody
🇺🇸Sandy Springs, Georgia, United States
Circle Medical Management
🇺🇸Chicago, Illinois, United States
RAI Palm Harbor, Outcomes Research Int'l
🇺🇸Hudson, Florida, United States
Affiliated Home Dialysis
🇺🇸Glen Ellyn, Illinois, United States
Nephrology, Inc.
🇺🇸Mishawaka, Indiana, United States
Kansas Dialysis Services
🇺🇸Topeka, Kansas, United States
University of Louisvile KDP
🇺🇸Louisville, Kentucky, United States
Dialysis at Home, Inc
🇺🇸Brighton, Massachusetts, United States
Great Lakes Renal Network
🇺🇸Alma, Michigan, United States
Munson Dialysis Center
🇺🇸Traverse City, Michigan, United States
NRA Home
🇺🇸Frontenac, Missouri, United States
Washington University/Barnes Jewish Dialysis Center
🇺🇸St. Louis, Missouri, United States
Dialysis Center of Lincoln
🇺🇸Lincoln, Nebraska, United States
Renal Advantage
🇺🇸Omaha, Nebraska, United States
Silver Care Center
🇺🇸Cherry Hill, New Jersey, United States
Lillian Booth Dialysis Center
🇺🇸Westwood, New Jersey, United States
Apollo Healthcare - Niagara Renal Center
🇺🇸Niagara Falls, New York, United States
Hortense and Louis Rubin Dialysis Center
🇺🇸Saratoga Springs, New York, United States
Community Physicians Dialysis Centers
🇺🇸Springfield, Ohio, United States
Wake Forest University/Piedmont Dialysis
🇺🇸Winston-Salem, North Carolina, United States
Wellspan Dialysis
🇺🇸York, Pennsylvania, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
Virginia Commonwealth University/Medical College of Virginia
🇺🇸Richmond, Virginia, United States
Commonwealth Dialysis
🇺🇸Greenfield, Wisconsin, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Barlite SW Kidney Center
🇺🇸San Antonio, Texas, United States