- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02851225
Coordinate Regulation of Transfusions by Uploading (RTT)
Currently in the Toulouse University Hospital, the organization of transfusion care for patients requiring regular transfusions is based on reading the biological results received by fax before confirming or disproving a planned hospitalization or program a new hospital if needed.
Remote transmission of laboratory results, replacing fax communication might facilitate the coordination of care that results from these laboratory results and provide a better respect of the Plan Custom Care Transfusion (PPST).
The investigators offer organization of transfusion supportive care for patients with conditions requiring biological monitoring using the techniques of information and communication telemedicine.
Primary objective
- Assess the feasibility of setting up an upload procedure biological results in the treatment of transfusion supportive care.
Secondary objectives
- Assess the evolution of the quality of life of patients during the treatment
- Assess changes in patient satisfaction over the support
- Assess the evolution of the satisfaction of the medical team at home and at Toulouse University Hospital
- Describe the programming time (hospitalization, consultations)
- Estimate the loss of biological results
- Assessment of the descriptive use of hospitalization, consultation and biological examinations in both groups. This remedy shall be valued in Euros thanks to GHS rates for hospitalizations, general nomenclature for Professional acts (NGAP) and biology nomenclature (NABM) for biological tests.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Setting up a Custom Care Plan for patients with conditions requiring a transfusion followed , which in its development provides a transfusion Care Custom Program .
The establishment of an electronic transmission enables the regulation of all hospitalizations throughout the patient care pathway and reinforces the link city / hospital through the receipt of laboratory results and issuing information to the partners of the care network patient. The PPST will be transmitted by secure messaging.
The primary endpoint is the proportion of transfusion episodes where PPST is respected. The proportion of patients whose care meets the PPST for 3 successive transfusion episodes will also be estimated.
The secondary endpoints are:
- The Patient satisfaction questionnaires (relative to the consideration of the results, the management procedures) in 3 successive transfusions.
- The Quality of life of the patient assessed by questionnaire (EORTC-QLQC30 and EQ5D) at baseline and after 3 successive transfusion episodes.
- The Satisfaction surveys of the medical team at home and the service effector transfusion at baseline and after 3 successive transfusion episodes.
- The Response time for a hospitalization or consultation program on the study period.
- The Number of lost biological results.
- Evaluation of the descriptive use of hospitalization, consultation, biology.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Toulouse, Francia, 31059
- IUCT-O
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients receiving blood transfusions and / or platelet on our hospital
- Patient agreeing to participate in the project
Exclusion Criteria:
- A patient who can not fill questionaries.
- Absence of social coverage .
- Patient under guardianship or trusteeship safeguard justice
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: telemedicine transmission
telemedicine transmission of biological results in the treatment of transfusion supportive care
|
telemedicine transmission of biological informations
|
Sin intervención: without telemedicine transmission
no telemedicine transmission of biological results in treatment in the treatment of transfusion supportive care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Proportion of transfusion episodes in the Plan Custom Care Transfusion
Periodo de tiempo: 12 months
|
The primary endpoint chosen is the proportion of transfusion episodes where the Plan Custom Care Transfusion is respected. The element determining compliance will be: - Transfusion with remote transmission, and transfusion in a service defined in the Plan Custom Care Transfusion and transfusion with achievement of target hemoglobin levels |
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quality of life of patients
Periodo de tiempo: 12 months
|
Assess the evolution of the quality of life of patients ( EORTC- QLQC30 questionnaires and EQ5D )
|
12 months
|
Patients satisfaction
Periodo de tiempo: 12 months
|
Assess changes in patient satisfaction ( satisfaction survey compared to the overall care , the inclusion of the results, the management procedures )
|
12 months
|
Satisfaction of medical team
Periodo de tiempo: 12 months
|
Assess the evolution of the satisfaction of the medical team at home and in Hospital ( satisfaction surveys )
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Odile Beyne Rauzy, MD, University Hospital, Toulouse
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
Otros números de identificación del estudio
- 12 559 15
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre telemedicine transmission of biological results
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Shanghai Institute Of Biological ProductsTerminado