- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01261910
Enhancing Education Regarding Living Donor Transplant Among Kidney Transplant Candidates
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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New Jersey
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Livingston, New Jersey, 미국, 07039
- Saint Barnabas Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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:
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
기간: Up to 1 week after the transplant education day
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Up to 1 week after the transplant education day
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
기간: Three months after the transplant education day
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Three months after the transplant education day
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Attitudes, confidence, and opinions regarding living kidney donation and LDKT
기간: (1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
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(1) Up to 1 week after the transplant education day, and (2) Three months after the transplant education day
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Changes in knowledge/understanding and attitudes/confidence/opinions regarding living kidney donation and LDKT
기간: (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)
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(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)
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Francis L Weng, MD, St. Barnabas Medical Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .