Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

Chronic Kidney Disease Clinical Trial

Official title:

Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01261910
• Other study ID #: SBMC-2009-53
• Status: Completed
• Phase: N/A
• First received: December 14, 2010
• Last updated: July 25, 2014
• Start date: December 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2014
• Source: St. Barnabas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Kidney Transplant
• Living-Donor Kidney Transplant
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Saint Barnabas Medical Center	Livingston	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
St. Barnabas Medical Center	Health Resources and Services Administration (HRSA), University of Medicine and Dentistry of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT		Up to 1 week after the transplant education day	No
Secondary	Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT		Three months after the transplant education day	No
Secondary	Attitudes, confidence, and opinions regarding living kidney donation and LDKT		(1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day	No
Secondary	Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT		(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)	No