- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03071939
Cognate Patient Care Insight Scale (EIPSP)
Pilot Study of a New Insight Assessment Tool
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Bron Cedex, Francia, 69678
- Centre Hospitalier Le Vinatier
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosis of schizophrenia
- Age from 18 to 50 years old
- Stabilized clinical condition (without therapeutic modification during the month prior to inclusion)
- French language read, spoken and understood (patient and family member)
- Having given his consent
- Agreement of the guardian for persons under guardianship
- Consent of the relative
Exclusion Criteria:
- Refusal of patient or legal guardian
- Refusal of the loved one
- Patient and / or neurological disorder of neurological origin of vascular, infectious or neurodegenerative origin
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: patients with schizophrenia and their designated relatives
Evaluation of the patient's insight (an inclusion phase, followed by two evaluation phases on D0 and D7) by the patient, his / her close and two caregivers (inter-judicial fidelity)
|
This study will evaluate the insight of the patient, something carried out in common practice within the Eastern Pole (CH Le Vinatier). This assessment will take place in the specific services where patients are cared for. It will make it possible to evaluate insight more closely by comparing the opinions of the three actors. There is no risk in this study. The study will be carried out over 2 years with a recruitment of 119 patients responding to the diagnosis of schizophrenia, taken care of within the Eastern Pole (Intra and Extrahospital services). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Concurrent validity of the hetero-evaluation scale by studying its correlation with the results obtained, for the same persons, on the SUMD scale (Scale to Assess Unawareness of Mental Disorder)
Periodo de tiempo: two years
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Correlation higher than 0.40 in the Bravais-Pearson test between the caregiver's hetero-evaluation scale and the Scale to Assess Understanding of Mental Disorder (SUMD)
|
two years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Correlation greater than 0.40 to inter-judge fidelity to Cohen's Kappa test
Periodo de tiempo: two years
|
Inter-judicial fidelity will be measured with Cohen's Kappa test, which is a coefficient to measure the agreement between two qualitative variables with the same modalities. Conventionally, it is used to measure the degree of concordance between the stages Awarded by two judges. It can also be applied to measure an intra-observer agreement. The closer the ratio is to 1, the closer the gap between the observed chord proportion and the theoretical proportion of "random" chords approaches the gap between the perfect tuning of the two observers and their random match. The coefficient is always between -1 and 1 (maximum agreement). |
two years
|
|
Cronbach's alpha coefficient with a value of 0.7 measuring internal consistency
Periodo de tiempo: two years
|
Internal consistency will be measured with the Cronbach alpha coefficient, sometimes referred to simply as the coefficient. Which is a statistic used especially in psychometrics to measure the internal consistency (or reliability) of the questions asked during a test (the answers to the questions on the same subject to be correlated). Its value is between 0 and 1, being considered "acceptable" from 0.7. It therefore allows estimation of the fidelity of the score to a test. |
two years
|
|
Correlation greater than 0.40 at the Bravais-Pearson test measuring test fidelity, re-testing
Periodo de tiempo: two years
|
This coefficient makes it possible to detect the presence or absence of a linear relationship between two continuous quantitative characters.
To calculate this coefficient, one must first calculate the covariance.
Covariance is the mean of the product of deviations from the mean.
The linear correlation coefficient of two characters X and Y is equal to the covariance of X and Y divided by the product of the standard deviations of X and Y.
It can be shown that this coefficient varies between -1 and +1
|
two years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: MAGES Nicolas, MDPH, Centre Hospitalier Le Vinatier
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
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 (Actual)
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
- 2016-A01716-45
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.
producto fabricado y exportado desde los EE. UU.
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