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.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Creteil
-
Créteil, Creteil, Frankrike, 94000
- Marciano Joelle
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Description of the patient's feelings
Tidsramme: up to 1 month after diagnosis
|
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.
|
up to 1 month after diagnosis
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
score of general satisfaction
Tidsramme: up to 1 month after diagnosis
|
the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)
|
up to 1 month after diagnosis
|
|
score on a comprehension quiz on AMD
Tidsramme: up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
Score on a composite score evaluating the clarity of medical explanations
Tidsramme: up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
Score on a composite score evaluating the clarity of medical explanations
Tidsramme: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
score of satisfaction of announcement conditions
Tidsramme: up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
score of satisfaction of announcement conditions
Tidsramme: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
score of satisfactions regarding the clarity of the disease course and treatment explanations
Tidsramme: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
Score on the anxiety PHQ9 questionnaire
Tidsramme: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
Score on the anxiety GAD7 questionnaire
Tidsramme: between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PANDA
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .