Clinical trial NCT01261910: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Living-Donor Kidney Transplant
Chronic Kidney Disease
End-stage Renal Disease
Lead sponsor: St. Barnabas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Medicine and Dentistry of New Jersey
name: Health Resources and Services Administration (HRSA)
First posted: 2010-12-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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:

Primary outcomes:
measure: Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
timeFrame: Up to 1 week after the transplant education day
Secondary outcomes:
measure: Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
timeFrame: Three months after the transplant education day
measure: Attitudes, confidence, and opinions regarding living kidney donation and LDKT
timeFrame: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
measure: Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT
timeFrame: (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)
Other outcomes:
Locations:
city: Livingston
country: United States
facility: Saint Barnabas Medical Center
state: New Jersey
Study officials:
affiliation: St. Barnabas Medical Center
name: Francis L Weng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.