Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Description of the patient's feelings
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patient up to 55 years old
- •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
排除标准
- •patient under 55 years old
- •patient who doesn't speak French
- •patient carrying an ophtalmologic genetic disorder
结局指标
主要结局
Description of the patient's feelings
时间窗: 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.
次要结局
- Score on the anxiety PHQ9 questionnaire(between 6 months and 1 year of follow-up)
- score of satisfaction of announcement conditions(between 6 months and 1 year of follow-up)
- score on a comprehension quiz on AMD(up to 1 month after diagnosis)
- score of general satisfaction(up to 1 month after diagnosis)
- Score on a composite score evaluating the clarity of medical explanations(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)
- Score on the anxiety GAD7 questionnaire(between 6 months and 1 year of follow-up)
研究者
Joëlle Marciano
Orthoptist in the ophtalmologic department of the CHI Creteil
Centre Hospitalier Intercommunal Creteil