Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

• Sponsor: St. Barnabas Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01261910
• Collaborator: University of Medicine and Dentistry of New Jersey (Other), Health Resources and Services Administration (HRSA) (U.S. Fed)
• Enrollment: 500
• Location: 1
• Arms: 2
• Duration (Months): 30
• Patients Per Site Per Month: 16.7

Study Details

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant; Living-Donor Kidney Transplant; Chronic Kidney Disease; End-stage Renal Disease	Behavioral: Intensive initial education	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 500 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. 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]

2. 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]

3. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Barnabas Medical Center	Livingston	New Jersey	United States	07039

Sponsors and Collaborators

• St. Barnabas Medical Center
• University of Medicine and Dentistry of New Jersey
• Health Resources and Services Administration (HRSA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Barnabas Medical Center
• ClinicalTrials.gov Identifier: NCT01261910
• Other Study ID Numbers: SBMC-2009-53
• First Posted: Dec 17, 2010
• Last Update Posted: Jul 28, 2014
• Last Verified: Jul 1, 2014

• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Study Results

No Results Posted as of Jul 28, 2014