Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration

Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03035461

Acronym

PANDA

Enrollment

250

Registered

2017-01-30

Start date

2017-03-15

Completion date

2018-10-19

Last updated

2020-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Keywords

diagnosis annoucement, patient's feelings

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Description of the patient's feelings	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.

Secondary

Measure	Time frame	Description
score on a comprehension quiz on AMD	up to 1 month after diagnosis	—
Score on a composite score evaluating the clarity of medical explanations	up to 1 month after diagnosis	—
score of satisfaction of announcement conditions	up to 1 month after diagnosis	—
score of general satisfaction	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)
Score on the anxiety PHQ9 questionnaire	between 6 months and 1 year of follow-up	—
Score on the anxiety GAD7 questionnaire	between 6 months and 1 year of follow-up	—
score of satisfactions regarding the clarity of the disease course and treatment explanations	between 6 months and 1 year of follow-up	—

Countries

France

Outcome results