Clinical trial NCT00288613: FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
Official title: FREEDOM: Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure, Chronic
End Stage Renal Disease, Requiring Dialysis
Keywords: ESRD
Daily Hemodialysis
Hemodialysis
Kidney Failure
Kidney Disease
Lead sponsor: NxStage Medical
Sponsor class: OTHER
First posted: 2006-02-08
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Hospitalizations
timeFrame: duration of study participation
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Smith
country: United States
facility: Fort Smith Regional Dialysis Center
state: Arkansas
city: Hot Springs
country: United States
facility: Arkansas Nephrology Research Associates
state: Arkansas
city: Garden Grove
country: United States
facility: Renal Advantage (RAI)
state: California
city: Mountain View
country: United States
facility: Satellite Healthcare/Wellbound
state: California
city: Oakland
country: United States
facility: Renal Advantage (RAI)
state: California
city: Simi Valley
country: United States
facility: Kidney Center, Inc.
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Metabolism Associates - New Haven CAPD
state: Connecticut
city: Hudson
country: United States
facility: RAI Palm Harbor, Outcomes Research Int'l
state: Florida
city: Sandy Springs
country: United States
facility: Emory, Renal Care Partners of Dunwoody
state: Georgia
city: Chicago
country: United States
facility: Circle Medical Management
state: Illinois
city: Glen Ellyn
country: United States
facility: Affiliated Home Dialysis
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Mishawaka
country: United States
facility: Nephrology, Inc.
state: Indiana
city: Topeka
country: United States
facility: Kansas Dialysis Services
state: Kansas
city: Louisville
country: United States
facility: University of Louisvile KDP
state: Kentucky
city: Brighton
country: United States
facility: Dialysis at Home, Inc
state: Massachusetts
city: Alma
country: United States
facility: Great Lakes Renal Network
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Traverse City
country: United States
facility: Munson Dialysis Center
state: Michigan
city: Wyoming
country: United States
facility: Renal Advantage (RAI)
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Frontenac
country: United States
facility: NRA Home
state: Missouri
city: St. Louis
country: United States
facility: Washington University/Barnes Jewish Dialysis Center
state: Missouri
city: Lincoln
country: United States
facility: Dialysis Center of Lincoln
state: Nebraska
city: Omaha
country: United States
facility: Renal Advantage
state: Nebraska
city: Cherry Hill
country: United States
facility: Silver Care Center
state: New Jersey
city: Westwood
country: United States
facility: Lillian Booth Dialysis Center
state: New Jersey
city: Niagara Falls
country: United States
facility: Apollo Healthcare - Niagara Renal Center
state: New York
city: Saratoga Springs
country: United States
facility: Hortense and Louis Rubin Dialysis Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University/Piedmont Dialysis
state: North Carolina
city: Springfield
country: United States
facility: Community Physicians Dialysis Centers
state: Ohio
city: York
country: United States
facility: Wellspan Dialysis
state: Pennsylvania
city: Charleston
country: United States
facility: Renal Advantage (RAI)
state: South Carolina
city: Chattanooga
country: United States
facility: Chattanooga Kidney Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: San Antonio
country: United States
facility: Barlite SW Kidney Center
state: Texas
city: Hampton
country: United States
facility: Renal Advantage (RAI)
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Medical College of Virginia
state: Virginia
city: Seattle
country: United States
facility: Northwest Kidney Centers
state: Washington
city: Greenfield
country: United States
facility: Commonwealth Dialysis
state: Wisconsin
Study officials:
affiliation: Unaffilated
name: Bertrand L. Jaber, MD, FASN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finkelstein FO, Schiller B, Daoui R, Gehr TW, Kraus MA, Lea J, Lee Y, Miller BW, Sinsakul M, Jaber BL. At-home short daily hemodialysis improves the long-term health-related quality of life. Kidney Int. 2012 Sep;82(5):561-9. doi: 10.1038/ki.2012.168. Epub 2012 May 23.
citation: Jaber BL, Schiller B, Burkart JM, Daoui R, Kraus MA, Lee Y, Miller BW, Teitelbaum I, Williams AW, Finkelstein FO; FREEDOM Study Group. Impact of short daily hemodialysis on restless legs symptoms and sleep disturbances. Clin J Am Soc Nephrol. 2011 May;6(5):1049-56. doi: 10.2215/CJN.10451110. Epub 2011 Mar 17.
citation: Jaber BL, Finkelstein FO, Glickman JD, Hull AR, Kraus MA, Leypoldt JK, Liu J, Gilbertson D, McCarthy J, Miller BW, Moran J, Collins AJ; FREEDOM Study Group. Scope and design of the Following Rehabilitation, Economics and Everyday-Dialysis Outcome Measurements (FREEDOM) Study. Am J Kidney Dis. 2009 Feb;53(2):310-20. doi: 10.1053/j.ajkd.2008.07.013. Epub 2008 Sep 27.