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

July 22, 2014 updated by: NxStage Medical
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Fort Smith Regional Dialysis Center
      • Hot Springs, Arkansas, United States, 71901
        • Arkansas Nephrology Research Associates
    • California
      • Garden Grove, California, United States, 92843
        • Renal Advantage (RAI)
      • Mountain View, California, United States, 94041
        • Satellite Healthcare/Wellbound
      • Oakland, California, United States, 94612
        • Renal Advantage (RAI)
      • Simi Valley, California, United States, 93065
        • Kidney Center, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Metabolism Associates - New Haven CAPD
    • Florida
      • Hudson, Florida, United States, 34667
        • RAI Palm Harbor, Outcomes Research Int'l
    • Georgia
      • Sandy Springs, Georgia, United States, 30350
        • Emory, Renal Care Partners of Dunwoody
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Circle Medical Management
      • Glen Ellyn, Illinois, United States, 60137
        • Affiliated Home Dialysis
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
      • Mishawaka, Indiana, United States, 46545
        • Nephrology, Inc.
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Kansas Dialysis Services
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisvile KDP
    • Massachusetts
      • Brighton, Massachusetts, United States, 02135
        • Dialysis at Home, Inc
    • Michigan
      • Alma, Michigan, United States, 48801
        • Great Lakes Renal Network
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Traverse City, Michigan, United States, 49684
        • Munson Dialysis Center
      • Wyoming, Michigan, United States, 49509
        • Renal Advantage (RAI)
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Frontenac, Missouri, United States, 63131
        • NRA Home
      • St. Louis, Missouri, United States, 63108
        • Washington University/Barnes Jewish Dialysis Center
    • Nebraska
      • Lincoln, Nebraska, United States, 66510
        • Dialysis Center of Lincoln
      • Omaha, Nebraska, United States, 68198
        • Renal Advantage
    • New Jersey
      • Cherry Hill, New Jersey, United States, 07675
        • Silver Care Center
      • Westwood, New Jersey, United States, 07675
        • Lillian Booth Dialysis Center
    • New York
      • Niagara Falls, New York, United States, 14304
        • Apollo Healthcare - Niagara Renal Center
      • Saratoga Springs, New York, United States, 12866
        • Hortense and Louis Rubin Dialysis Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University/Piedmont Dialysis
    • Ohio
      • Springfield, Ohio, United States, 45505
        • Community Physicians Dialysis Centers
    • Pennsylvania
      • York, Pennsylvania, United States, 15198
        • Wellspan Dialysis
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Renal Advantage (RAI)
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Chattanooga Kidney Center
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • San Antonio, Texas, United States, 78224
        • Barlite SW Kidney Center
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Renal Advantage (RAI)
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Medical College of Virginia
    • Washington
      • Seattle, Washington, United States, 98122
        • Northwest Kidney Centers
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53220
        • Commonwealth Dialysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
duration of study participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NxStage Medical

Investigators

  • Principal Investigator: Bertrand L. Jaber, MD, FASN, Unaffilated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

February 6, 2006

First Submitted That Met QC Criteria

February 6, 2006

First Posted (Estimate)

February 8, 2006

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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