- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02763943
Improving Medication Safety and CVD Risk Factor Control in Kidney Transplant Recipients
Improving Medication Safety and Cardiovascular Risk Factor Control in Kidney Transplant Recipients
There is a lack of data analyzing the influence of Cardio-vascular Diseases (CVD) risk factor control on graft survival disparities in Black transplant recipients. Studies in the general population indicate that CVD risk factor control is poor in Black patients, leading to higher rates of renal failure and CV events. However, with the exception of hypertension, there is paucity in data demonstrating similar results within transplant recipients. Recent analyses conducted within our transplant program, indicate that CVD risk factors, especially diabetes, are poorly controlled in Black recipients, which likely impacts graft loss. Since these data were collected in a retrospective manner, larger analyses are needed to validate these exploratory findings.
This pilot study is to:
- Determine if the study is feasible, as measured by the proportions of enrolled to approached and completed to enrolled.
- Measure and compare, at baseline versus the end of the intervention, the medication safety events, including the number of medication errors, medication non-adherence and medication side effects, in patients enrolled in the study
- Measure and compare, at baseline versus the end of the intervention, CVD risk factor control, including hypertension, diabetes and dyslipidemia, in patients enrolled in the study
- Measure and compare, at baseline versus the end of the intervention, patient reported survey results, in patients enrolled in the study
- Determine if the impact of the intervention is more pronounced in Black recipients, as compared to non-Black recipients
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- At least 18 years of age and able to give informed consent.
- Received a first or repeat cadaveric or living donor renal transplant.
- Patient has adequate graft function, defined as an estimated glomerular filtration rate (GFR) of at least 20 mL/min, using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
- Patient is at least one year post transplant.
- Patient has documented hypertension, defined as a sitting blood pressure of at least 140/90 mmHg or receiving any anti-hypertensive therapy.
- Patient has documented diabetes mellitus, defined as a hemoglobin A1c of at least 6.5% or receiving any anti-glycemic medications.
- Willing to comply with all study visits.
Exclusion Criteria:
- Biopsy proven acute rejection episode that occurred within the past month.
- Patients who have received an organ transplant other than a kidney.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in blood pressure values from baseline to end of study
Periodo de tiempo: 6 months
|
Blood pressure will be assessed using clinic measurements, taken three times, five minutes apart in the same arm and averaged.
|
6 months
|
|
Change in HBA1C values from baseline to end of study
Periodo de tiempo: 6 months
|
6 months
|
|
|
Change in lipid values from baseline to end of study
Periodo de tiempo: 6 months
|
6 months
|
|
|
Medication adherence by comparing medication possession ratios (MPR) for the six months prior to enrollment compared to six months during the intervention
Periodo de tiempo: 1 year
|
1 year
|
|
|
Patient self-reported medication adherence at baseline compared to end of study.
Periodo de tiempo: 6 months
|
The Morisky 8-item adherence score will be compared from baseline to end of study.
|
6 months
|
|
Number of medication errors assessed at baseline and compared to errors at 6 months
Periodo de tiempo: 6 months
|
6 months
|
|
|
Medication side effects at baseline compared to end of study.
Periodo de tiempo: 6 months
|
The Memphis side effect scale will be used to compare side effects from baseline to end of study.
|
6 months
|
|
Patient reported survey results regarding self-care and health knowledge from baseline to end of study
Periodo de tiempo: 6 months
|
6 months
|
|
|
Patient reported survey results regarding psychosocial status from baseline to end of study
Periodo de tiempo: 6 months
|
6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- Pro00051804
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. .