Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

July 25, 2014 updated by: St. Barnabas Medical Center

The primary purpose of this study is to test different methods by which kidney transplant centers can educate potential transplant candidates about living donor kidney transplant (LDKT).

The most effective ways to educate kidney transplant candidates about LDKT remain unclear. The goal is to determine, among a diverse cohort of potential kidney transplant candidates, whether a transplant center-based intervention will increase understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT. The investigators hypothesize that kidney transplant candidates' understanding of living kidney donation and LDKT will be increased by interventions implemented at the transplant center on the day of transplant evaluation.

The investigators propose a single-center, 2-arm, cluster-randomized, controlled trial to compare the effects of two educational strategies upon transplant candidates' understanding of living kidney donation and LDKT:

  1. Usual transplant education implemented by the transplant center, on the day of the transplant evaluation (standard care); and
  2. Intensive initial transplant education implemented on the day of the transplant evaluation.

Intensive initial transplant education will utilize videos of living donors' experiences as well as a session with a trained Transplant Educator, who will focus upon living donation education. One week after the transplant evaluation day and 3 months later, the investigators will assess transplant candidates' knowledge of LDKT (using questionnaires), identify correlates of increased understanding of LDKT, and assess racial/ethnic differences in the understanding of LDKT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

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
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Appear for initial kidney transplant evaluation at Saint Barnabas Medical Center
  • 18 years of age or older
  • Able to provide informed consent
  • Able to speak, hear, and understand English

Exclusion Criteria:

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual education (standard care)
On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant.
Experimental: Intensive initial education
On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant. In addition, participants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person.
Behavioral: Intensive initial education
Participants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Time Frame: Up to 1 week after the transplant education day
Up to 1 week after the transplant education day

Secondary Outcome Measures

Outcome Measure
Time Frame
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Time Frame: Three months after the transplant education day
Three months after the transplant education day
Attitudes, confidence, and opinions regarding living kidney donation and LDKT
Time Frame: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
(1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT
Time Frame: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day, compared to prior to the transplant evaluation day (baseline)
(1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day, compared to prior to the transplant evaluation day (baseline)

Collaborators and Investigators

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

Sponsor

St. Barnabas Medical Center

Collaborators

Health Resources and Services Administration (HRSA)
University of Medicine and Dentistry of New Jersey

Investigators

  • Principal Investigator: Francis L Weng, MD, St. Barnabas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 16, 2010

First Posted (Estimate)

December 17, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2014

Last Update Submitted That Met QC Criteria

July 25, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMC-2009-53

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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