- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02410538
Frequently Asked Questions for ICU Patients' Families (FamiréaXVII)
Frequently Asked Questions as an Help to Improve the Information of ICU Patients' Families.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Half of the families of ICU patients do not understand the information provided by doctors and nurses. Receiving clear, loyal and appropriate information is one of their main expectations. We have previously reported that relatives had difficulty asking questions that allow them to improve their understanding regarding ICU issues. In a preliminary study, we developed a list of questions considered as important by families, ICU doctors and nurses.
The aim of this prospective, randomized and controlled trial is to test the effectiveness of a list of frequently asked questions to relatives of ICU patients on their understanding of the provided information.
The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of ICU stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Marseille, Francia, 13354
- Hôpital Nord Assistance Publique Hôpitaux de Marseille
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
The subjects that will be included are relatives of patients. The patients must be
- Adults
- Receiving invasive mechanical ventilation
- Intubated in the first 48 hours of ICU admission
- For an expected duration of mechanical ventilation > 48 hours
- With a life expectancy of at least 5 days and a SAPS 2 at baseline < 75
- Who received a visit within 24 hours after intubation. Only one relative will be included.
Exclusion Criteria:
- person unable to read French
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
families that received the list of "FAQ"
The intervention consists of the delivery to the relatives of ICU patients a list of "21 key issues" in intensive care during the first 48h period of ICU stay, only for intubated and mechanically ventilated patients A formal interview is scheduled to relatives of ICU patients on D3 of inclusion
|
|
|
families that received information as usual
A formal interview is scheduled relatives of ICU patients on D3 inclusion
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Evaluation of understanding at day 5 by a method of reformulation questionnaire
Periodo de tiempo: 5th day after inclusion
|
The physician in charge of the patient provides the diagnosis, the treatment and the prognosis to the investigator prior to meet the relative. After the meeting, the relative gives to the investigator the diagnosis, main treatements and the prognosis as they have undestood them. In a final step, the investigator will indicate whether similar responses are consistent or not consistent. |
5th day after inclusion
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|
Scale of satisfaction out of intensive care.
Periodo de tiempo: 3 months and at one yearfter inclusion
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HADS scores and IES-R at day 5 to day 10.
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3 months and at one yearfter inclusion
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Colaboradores e Investigadores
Patrocinador
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
- RC12_3678
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. .
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-
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-
University of StellenboschTerminado
-
University of Colorado, DenverReclutamientoDepresión post-partoEstados Unidos
-
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