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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Creteil
-
Créteil、Creteil、フランス、94000
- Marciano Joelle
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Description of the patient's feelings
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
score of general satisfaction
時間枠：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
時間枠：up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
Score on a composite score evaluating the clarity of medical explanations
時間枠：up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
Score on a composite score evaluating the clarity of medical explanations
時間枠：between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
score of satisfaction of announcement conditions
時間枠：up to 1 month after diagnosis
|
up to 1 month after diagnosis
|
|
|
score of satisfaction of announcement conditions
時間枠：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
時間枠：between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
Score on the anxiety PHQ9 questionnaire
時間枠：between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
|
|
Score on the anxiety GAD7 questionnaire
時間枠：between 6 months and 1 year of follow-up
|
between 6 months and 1 year of follow-up
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。