Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

NCT01261910 | Completed

• 1 other identifier: SBMC-2009-53
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• 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

• 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

• 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)

Study Arms (2)

Usual education (standard care)

NO INTERVENTION

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

Intensive initial education

EXPERIMENTAL

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

Interventions

Intensive initial education 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.

Intensive initial education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Related Publications (2)

• 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.

  PMID: 36472416 DERIVED

• 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.

  PMID: 24245948 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francis L Weng, MD

  St. Barnabas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 28, 2014

Record last verified: 2014-07

Locations

US (1)