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

NCT ID: NCT00288613

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 501 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2013-11-30

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.

Conditions

Kidney Failure, Chronic; End Stage Renal Disease, Requiring Dialysis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NxStage Medical

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand L. Jaber, MD, FASN

Role: PRINCIPAL_INVESTIGATOR

Unaffilated

Locations

Fort Smith Regional Dialysis Center

Fort Smith, Arkansas, United States

Arkansas Nephrology Research Associates

Hot Springs, Arkansas, United States

Renal Advantage (RAI)

Garden Grove, California, United States

Satellite Healthcare/Wellbound

Mountain View, California, United States

Renal Advantage (RAI)

Oakland, California, United States

Kidney Center, Inc.

Simi Valley, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Metabolism Associates - New Haven CAPD

New Haven, Connecticut, United States

RAI Palm Harbor, Outcomes Research Int'l

Hudson, Florida, United States

Emory, Renal Care Partners of Dunwoody

Sandy Springs, Georgia, United States

Circle Medical Management

Chicago, Illinois, United States

Affiliated Home Dialysis

Glen Ellyn, Illinois, United States

Indiana University Medical Center

Indianapolis, Indiana, 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

Henry Ford Health System

Detroit, Michigan, United States

Munson Dialysis Center

Traverse City, Michigan, United States

Renal Advantage (RAI)

Wyoming, Michigan, United States

Mayo Clinic

Rochester, Minnesota, 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

Wake Forest University/Piedmont Dialysis

Winston-Salem, North Carolina, United States

Community Physicians Dialysis Centers

Springfield, Ohio, United States

Wellspan Dialysis

York, Pennsylvania, United States

Renal Advantage (RAI)

Charleston, South Carolina, United States

Chattanooga Kidney Center

Chattanooga, Tennessee, United States

University of Texas Medical Branch

Galveston, Texas, United States

Barlite SW Kidney Center

San Antonio, Texas, United States

Renal Advantage (RAI)

Hampton, Virginia, United States

Virginia Commonwealth University/Medical College of Virginia

Richmond, Virginia, United States

Northwest Kidney Centers

Seattle, Washington, United States

Commonwealth Dialysis

Greenfield, Wisconsin, United States

Countries

United States

References

Cheetham MS, Ethier I, Krishnasamy R, Cho Y, Palmer SC, Johnson DW, Craig JC, Stroumza P, Frantzen L, Hegbrant J, Strippoli GF. Home versus in-centre haemodialysis for people with kidney failure. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD009535. doi: 10.1002/14651858.CD009535.pub3.

Reference Type: DERIVED

PMID: 38588450 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22622497 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21415315 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18823688 (View on PubMed)

Other Identifiers

CP0009

Identifier Type: -

Identifier Source: org_study_id