- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01439516
Providing Resources to Enhance African American Patients' Readiness to Make Decisions About Kidney Disease (PREPARED) Study (PREPARED)
Information and Financial Interventions for Kidney Donation in African Americans
African Americans are less likely than Whites to receive kidney transplants, despite their being more than two-fold as likely as Whites to develop end stage renal disease (ESRD). Living related kidney donation (LD) offers patients an opportunity to bypass many barriers to receipt of deceased kidney transplants (e.g. waiting lists and immunological incompatibility), but minorities are less likely to receive living related kidney transplants (LRT). Evidence suggests African Americans may not discuss LD/LRT with their families or physicians at optimal rates, and thus may not have adequate information to initiate or participate in shared decision-making regarding LD/LRT. African Americans may also have financial concerns regarding convalescence and out of pocket expenses related to LD/LRT, another barrier impeding LD/LRT.
The primary goals of this study are to overcome these important barriers by enhancing ethnic minorities' consideration of LD/LRT through the promotion of shared decision-making regarding LD/LRT and provision of financial assistance for out of pocket expenses. The investigators specific aims are: a) to develop culturally sensitive informational (audiovisual) and financial interventions and b) to perform a randomized controlled trial to assess their effectiveness in increasing pursuit of LD/LRT among African American patients with ESRD and their families. The investigators hypothesize: (1) Patients and families who view informational materials designed to promote shared decision-making regarding LD/LRT will be more likely than patients and families not viewing these materials to discuss LD/LRT with family and with health care professionals. Patients and families viewing such informational materials will also be more likely than those not viewing these materials to pursue and complete the LD/LRT process and (2) patients and their families who are offered the intervention to promote shared decision-making plus a financial assistance intervention for potential live kidney donors will be more likely than patients and families not offered both interventions to pursue and complete the LD/LRT process.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 or older
- End-stage renal disease (ESRD) receiving hemodialysis for less than 2 years
- Self-reported as African-American
- English Speaking
Exclusion Criteria:
- Dementia
- Prior Kidney Transplant
- Non-English Speaking
- Cancer within 2 years prior to recruitment date
- Stage 4 Congestive Heart Failure
- End Stage Liver Disease
- Unstable Coronary Artery Disease
- Pulmonary Hypertension
- Severe Peripheral Vascular Disease
- Chronic Debilitating Infections
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Information
Participants randomized to this arm of the study will received the PREPARED educational book and video.
|
Receipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD)
|
|
Experimental: Information and Financial Assistance
Participants randomized to this arm of the study will receive the PREPARED educational book and video plus financial assistance for family members to cover costs associated with an evaluation for becoming a live kidney donor.
|
Receipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD)
|
|
Sin intervención: Usual Care
Participants randomized to this arm of the study will receive usual care from their physician.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pursuit of Living Related Transplantation
Periodo de tiempo: 6 months
|
Measurement of patients' pursuit of LRT will be performed using a series of questions that assess the participants' knowledge, interest, and perceived barriers to LRT.
We will also ascertain use of the living donor financial assistance among potential donors and completion of evaluation and kidney transplant among both patient participants and potential living donors.
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Leigh Ebony Boulware, MD, Johns Hopkins University
Publicaciones y enlaces útiles
Publicaciones Generales
- Boulware LE, Ephraim PL, Ameling J, Lewis-Boyer L, Rabb H, Greer RC, Crews DC, Jaar BG, Auguste P, Purnell TS, Lamprea-Monteleagre JA, Olufade T, Gimenez L, Cook C, Campbell T, Woodall A, Ramamurthi H, Davenport CA, Choudhury KR, Weir MR, Hanes DS, Wang NY, Vilme H, Powe NR. Effectiveness of informational decision aids and a live donor financial assistance program on pursuit of live kidney transplants in African American hemodialysis patients. BMC Nephrol. 2018 May 3;19(1):107. doi: 10.1186/s12882-018-0901-x.
- Ephraim PL, Powe NR, Rabb H, Ameling J, Auguste P, Lewis-Boyer L, Greer RC, Crews DC, Purnell TS, Jaar BG, DePasquale N, Boulware LE. The providing resources to enhance African American patients' readiness to make decisions about kidney disease (PREPARED) study: protocol of a randomized controlled trial. BMC Nephrol. 2012 Oct 12;13:135. doi: 10.1186/1471-2369-13-135.
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 (Actual)
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
- NA_00011846
- 1R01DK079682-01 (Subvención/contrato del NIH de EE. UU.)
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. .