Transplant Navigator Dissemination

March 21, 2018 updated by: Catherine Sullivan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1926

Phase

  • Not Applicable

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
    • Indiana
      • Fort Wayne, Indiana, United States
        • Lutheran Hospital
    • Kentucky
      • Lexington, Kentucky, United States
        • University of Kentucky
      • Louisville, Kentucky, United States
        • Jewish Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States
        • The Ohio State University

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients who are wait listed or receive a kidney transplant.
Time Frame: approximately 3 years
approximately 3 years

Collaborators and Investigators

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

Sponsor

Catherine Sullivan

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 (Actual)

January 1, 2014

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 5, 2013

First Posted (Estimate)

November 11, 2013

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 21, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB12-00660

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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