Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration (PANDA)
Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA
Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".
Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.
After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.
The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Creteil
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Créteil, Creteil, Francia, 94000
- Marciano Joelle
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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 up to 55 years old
- wet AMD
- diagnostic questionnaire group: patient being announced with AMD for less than 1 month
- disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months
Exclusion Criteria:
- dry AMD
- patient under 55 years old
- patient who doesn't speak French
- patient carrying an ophtalmologic genetic disorder
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Description of the patient's feelings
Periodo de tiempo: up to 1 month after diagnosis
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A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis.
they can also explain their feelings by themselves.
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up to 1 month after diagnosis
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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score of general satisfaction
Periodo de tiempo: up to 1 month after diagnosis
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the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)
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up to 1 month after diagnosis
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score on a comprehension quiz on AMD
Periodo de tiempo: up to 1 month after diagnosis
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up to 1 month after diagnosis
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Score on a composite score evaluating the clarity of medical explanations
Periodo de tiempo: up to 1 month after diagnosis
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up to 1 month after diagnosis
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Score on a composite score evaluating the clarity of medical explanations
Periodo de tiempo: between 6 months and 1 year of follow-up
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between 6 months and 1 year of follow-up
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score of satisfaction of announcement conditions
Periodo de tiempo: up to 1 month after diagnosis
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up to 1 month after diagnosis
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score of satisfaction of announcement conditions
Periodo de tiempo: between 6 months and 1 year of follow-up
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between 6 months and 1 year of follow-up
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score of satisfactions regarding the clarity of the disease course and treatment explanations
Periodo de tiempo: between 6 months and 1 year of follow-up
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between 6 months and 1 year of follow-up
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Score on the anxiety PHQ9 questionnaire
Periodo de tiempo: between 6 months and 1 year of follow-up
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between 6 months and 1 year of follow-up
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Score on the anxiety GAD7 questionnaire
Periodo de tiempo: between 6 months and 1 year of follow-up
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between 6 months and 1 year of follow-up
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Colaboradores e Investigadores
Patrocinador
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PANDA
Plan de datos de participantes individuales (IPD)
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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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