Transplant Navigator Dissemination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01981603
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : March 22, 2018
Information provided by (Responsible Party):
Catherine Sullivan, MetroHealth Medical Center

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1926 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Actual Study Start Date : January 1, 2014
Primary Completion Date : December 2017
Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

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

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

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 identifier (NCT number): NCT01981603

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

Responsible Party: Catherine Sullivan, Center Manager, Research, MetroHealth Medical Center Identifier: NCT01981603     History of Changes
Other Study ID Numbers: IRB12-00660
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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

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