Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

NCT ID: NCT01261910

Last Updated: 2014-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Living-Donor Kidney Transplant Chronic Kidney Disease End-stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Intensive initial education

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role collaborator

Health Resources and Services Administration (HRSA)

FED

Sponsor Role collaborator

St. Barnabas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francis L Weng, MD

Role: PRINCIPAL_INVESTIGATOR

St. Barnabas Medical Center

Locations

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Saint Barnabas Medical Center

Livingston, New Jersey, United States

Site Status

Countries

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United States

References

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Campbell ZC, Dawson JK, Kirkendall SM, McCaffery KJ, Jansen J, Campbell KL, Lee VW, Webster AC. Interventions for improving health literacy in people with chronic kidney disease. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD012026. doi: 10.1002/14651858.CD012026.pub2.

Reference Type DERIVED
PMID: 36472416 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24245948 (View on PubMed)

Other Identifiers

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SBMC-2009-53

Identifier Type: -

Identifier Source: org_study_id

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