- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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Livingston, New Jersey, Estados Unidos, 07039
- Saint Barnabas Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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:
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Knowledge and understanding of the opportunities for and process, risks, and benefits of living kidney donation and LDKT
Periodo de tiempo: 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
Periodo de tiempo: (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
Periodo de tiempo: (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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Francis L Weng, MD, St. Barnabas Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SBMC-2009-53
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .