- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02971774
Development of a Multimodal Approach to Assess Stroke Patients Daily Life Activities
Development of a Multimodal Approach to Assess Stroke Persons Daily Life Activities and Development of a New Tool to Evaluate the Impact of Functional Activites on Quality of Life
Descripción general del estudio
Estado
Descripción detallada
- To conduct the research, a sociologist will collaborate with Doctor Nicolas Roche, the study director. The contribution of a sociologist will offer a viewpoint from outside the medical aspect, which will allow more global identification of the areas of the lives of patients that are affected by hemiparesis. Furthermore, the sociological perspective will seek to demonstrate the social aspects, which have heretofore been explored little or not at all in medical and public health studies, such as, for example, in terms of intimacy or self-image. It must delicately capture the practices, logic of action and though of the patients, by placing them in the social contexts in which they evolve and develop. Therefore, attention will be paid to certain "social determinants" (such as sociocultural setting, age or gender) and certain resources (particularly economic, relational and material), which can have an effect on the ways in which patients perceive and cope with the consequences of their hemiparesis. The role of loved ones (partner, family members, friends) will also be examined, since many sociological works have shown that they are usually on the front line to accompany, shape and manage the effects of the motor impairment.
- The study will target adults regularly followed in the department of physical medicine and rehabilitation of the Raymond-Poincaré hospital. These individuals must present with hemiparesis secondary to a single, hemispheric cerebrovascular accident, be living at home and be able to move inside and outside of the home.
Patients having several severe cognitive disorders or aphasia will not be interviewed.
The study will include an exploration phase (a corpus of approximatively 30 examinations) and a quantitative component (approximatively 100 questionnaires).
Once the examinations have been completed, the preparation of the questionnaire will be done with the validation of clinical experts. The questionnaire will include approximately 20 items, distributed over several dimensions of patients' lives. The participants' response time to the questionnaire should be in a range from 8 to 12 minutes, in order to facilitate its insertion in the professional practices when the patients are at a hospital visit.
The researcher will be in charge of completion of the questionnaire. This will be performed around or during the consultation of patients at Raymond-Poincaré hospital. The first completions will be recorded (with the written approval of surveyed patients) in order to be able to work on possible improvements, particularly in terms of the order of questions or in their understanding and response options. After ten completions, the questionnaire will be slightly revised if modifications appear necessary, then will remain the same until the desired volume of questionnaires is received (approximatively 100).
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Garches, Francia, 92380
- Reclutamiento
- Raymond Poincaré Hospital
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Contacto:
- Nicolas Roche, MD PhD
- Número de teléfono: 0033147105409
- Correo electrónico: roche.nicolas@aphp.fr
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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:
- Patient older than 18 years old
- patient with hemiparesis secondary to a single hemispheric cerebrovascular accident
- be living at home
- be able to move inside and outside of the home
Exclusion Criteria:
- Patients having several severe cognitive disorders
- Patients having severe aphasia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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questionnary
self administered questionnary
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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daily life questionnary
Periodo de tiempo: 45 minutes
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45 minutes
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2005997
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .