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Transplant Navigator Dissemination

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ClinicalTrials.gov Identifier: NCT01981603
Recruitment Status : Active, not recruiting
First Posted : November 11, 2013
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Primary Aim A. To disseminate and determine the impact of streamlined navigation on wait listing and number of transplants. The navigator will provide tailored information and assistance to help dialysis patients complete the tasks required at each step in the transplant process. In the control group, dialysis patients will continue to get usual care from their nephrologists and dialysis facility personnel.

Hypothesis: Compared to control patients, intervention patients will be significantly more likely to be wait listed or receive a kidney transplant.


Condition or disease Intervention/treatment
Kidney Transplant Renal Failure Chronic Requiring Hemodialysis Other: navigator

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: navigator
Kidney transplant recipients will serve as navigators to educate and assist other patients with the transplant process.
Other: navigator
No Intervention: usual care
usual care


Outcome Measures

Primary Outcome Measures :
  1. The proportion of patients who are wait listed or receive a kidney transplant. [ Time Frame: approximately 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between the ages of 18-70
  • receiving in center hemodialysis

Exclusion Criteria:

  • less than 18 years of age
  • older than 70 years of age
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981603


Locations
United States, Indiana
Lutheran Hospital
Fort Wayne, Indiana, United States
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States
Jewish Hospital
Louisville, Kentucky, United States
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
The Ohio State University
Columbus, Ohio, United States
Sponsors and Collaborators
Catherine Sullivan
More Information

Responsible Party: Catherine Sullivan, Center Manager, Research, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT01981603     History of Changes
Other Study ID Numbers: IRB12-00660
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017

Keywords provided by Catherine Sullivan, MetroHealth Medical Center:
Navigators
Kidney Transplant
Hemodialysis

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic