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Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

Primary Purpose

Kidney Transplant, Living-Donor Kidney Transplant, Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive initial education
Sponsored by
St. Barnabas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • Saint Barnabas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual education (standard care)

Intensive initial education

Arm Description

On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant.

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.

Outcomes

Primary Outcome Measures

Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT

Secondary Outcome Measures

Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Attitudes, confidence, and opinions regarding living kidney donation and LDKT
Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT

Full Information

First Posted
December 14, 2010
Last Updated
July 25, 2014
Sponsor
St. Barnabas Medical Center
Collaborators
University of Medicine and Dentistry of New Jersey, Health Resources and Services Administration (HRSA)
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1. Study Identification

Unique Protocol Identification Number
NCT01261910
Brief Title
Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates
Official Title
Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Barnabas Medical Center
Collaborators
University of Medicine and Dentistry of New Jersey, Health Resources and Services Administration (HRSA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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: Usual transplant education implemented by the transplant center, on the day of the transplant evaluation (standard care); and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplant, Living-Donor Kidney Transplant, Chronic Kidney Disease, End-stage Renal Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual education (standard care)
Arm Type
No Intervention
Arm Description
On the day of the transplant evaluation at the transplant center, participants receive usual transplant education regarding living donor kidney transplant.
Arm Title
Intensive initial education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intensive initial education
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis L Weng, MD
Organizational Affiliation
St. Barnabas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24245948
Citation
Weng FL, Brown DR, Peipert JD, Holland B, Waterman AD. Protocol of a cluster randomized trial of an educational intervention to increase knowledge of living donor kidney transplant among potential transplant candidates. BMC Nephrol. 2013 Nov 19;14:256. doi: 10.1186/1471-2369-14-256.
Results Reference
derived

Learn more about this trial

Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

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