NCT01981603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,926

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

3.9 years

First QC Date

October 30, 2013

Last Update Submit

March 21, 2018

Conditions

Kidney TransplantRenal Failure Chronic Requiring Hemodialysis

Keywords

NavigatorsKidney TransplantHemodialysis

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who are wait listed or receive a kidney transplant.

    approximately 3 years

Study Arms (2)

navigator

EXPERIMENTAL

Kidney transplant recipients will serve as navigators to educate and assist other patients with the transplant process.

Other: navigator

usual care

NO INTERVENTION

usual care

Interventions

navigatorOTHER
navigator

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • less than 18 years of age
  • older than 70 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Lutheran Hospital

Fort Wayne, Indiana, United States

Location

University of Kentucky

Lexington, Kentucky, United States

Location

Jewish Hospital

Louisville, Kentucky, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Ohio State University

Columbus, Ohio, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Center Manager, Research

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 11, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

US(5)