Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates
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Purpose
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:
- Usual transplant education implemented by the transplant center, on the day of the transplant evaluation (standard care); and
- 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 | Intervention |
|---|---|
|
Kidney Transplant Living-Donor Kidney Transplant Chronic Kidney Disease End-stage Renal Disease |
Behavioral: Intensive initial education |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates |
- Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT [ Time Frame: Up to 1 week after the transplant education day ] [ Designated as safety issue: No ]
- Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT [ Time Frame: Three months after the transplant education day ] [ Designated as safety issue: No ]
- Attitudes, confidence, and opinions regarding living kidney donation and LDKT [ Time Frame: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day ] [ Designated as safety issue: No ]
- Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT [ Time Frame: (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) ] [ Designated as safety issue: No ]
| Enrollment: | 500 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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| United States, New Jersey | |
| Saint Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| Principal Investigator: | Francis L Weng, MD | St. Barnabas Medical Center |
More Information
No publications provided
| Responsible Party: | St. Barnabas Medical Center |
| ClinicalTrials.gov Identifier: | NCT01261910 History of Changes |
| Other Study ID Numbers: | SBMC-2009-53 |
| Study First Received: | December 14, 2010 |
| Last Updated: | July 23, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |
ClinicalTrials.gov processed this record on May 16, 2013