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

Age Related Macular Degeneration Clinical Trial

— PANDA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035461
• Other study ID #: PANDA
• Status: Completed
• Start date: March 15, 2017
• Est. completion date: October 19, 2018

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 19, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
France	Marciano Joelle	Créteil	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

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