Back to resultsTransplant Navigator Dissemination
Primary Purpose
Kidney Transplant, Renal Failure Chronic Requiring Hemodialysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
navigator
Sponsored by
About this trial
This is an interventional supportive care trial for Kidney Transplant focused on measuring Navigators, Kidney Transplant, Hemodialysis
Eligibility 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
Sites / Locations
- Lutheran Hospital
- University of Kentucky
- Jewish Hospital
- MetroHealth Medical Center
- The Ohio State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
navigator
usual care
Arm Description
Kidney transplant recipients will serve as navigators to educate and assist other patients with the transplant process.
usual care
Outcomes
Primary Outcome Measures
The proportion of patients who are wait listed or receive a kidney transplant.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01981603
Brief Title
Transplant Navigator Dissemination
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catherine Sullivan
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant, Renal Failure Chronic Requiring Hemodialysis
Keywords
Navigators, Kidney Transplant, Hemodialysis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1926 (Actual)
8. Arms, Groups, and Interventions
Arm Title
navigator
Arm Type
Experimental
Arm Description
Kidney transplant recipients will serve as navigators to educate and assist other patients with the transplant process.
Arm Title
usual care
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
navigator
Primary Outcome Measure Information:
Title
The proportion of patients who are wait listed or receive a kidney transplant.
Time Frame
approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Lutheran Hospital
City
Fort Wayne
State/Province
Indiana
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Transplant Navigator Dissemination
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