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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Creteil
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Créteil, Creteil, Frankrijk, 94000
- Marciano Joelle
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Description of the patient's feelings
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
score of general satisfaction
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PANDA
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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