Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by St. Barnabas Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
University of Medicine and Dentistry of New Jersey
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
St. Barnabas Medical Center
ClinicalTrials.gov Identifier:
NCT01261910
First received: December 14, 2010
Last updated: July 23, 2012
Last verified: July 2012
  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:

  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 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

Resource links provided by NLM:


Further study details as provided by St. Barnabas Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261910

Locations
United States, New Jersey
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
  More Information

No publications provided by St. Barnabas Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 23, 2014