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.
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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-
Creteil
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Créteil、Creteil、法国、94000
- Marciano Joelle
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Description of the patient's feelings
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
score of general satisfaction
大体时间: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
大体时间:up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
Score on a composite score evaluating the clarity of medical explanations
大体时间:up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
Score on a composite score evaluating the clarity of medical explanations
大体时间:between 6 months and 1 year of follow-up
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between 6 months and 1 year of follow-up
|
|
score of satisfaction of announcement conditions
大体时间:up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
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score of satisfaction of announcement conditions
大体时间:between 6 months and 1 year of follow-up
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between 6 months and 1 year of follow-up
|
|
score of satisfactions regarding the clarity of the disease course and treatment explanations
大体时间:between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
Score on the anxiety PHQ9 questionnaire
大体时间:between 6 months and 1 year of follow-up
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between 6 months and 1 year of follow-up
|
|
Score on the anxiety GAD7 questionnaire
大体时间:between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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