Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place (DEMELE)
Age-related macular degeneration (AMD) is a disease that blurs the sharp, central vision you need for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail
The purpose of the study is to describe in patients with AMD and depending on the nature of their pathology (neovascular or atrophic):
(i) knowledge about their pathology (risk factors, symptoms, treatments, self-monitoring tool), (ii) their needs and (iii) impact on their daily lives
This study is to make an inventory of the knowledge of patients with AMD about their disease and risk factors using a questionnaire (Appendix 1) and to identify their needs, the impact of the disease on their daily lives during individual interviews by raising the recurrent data and confronting them during the focus group. The information gathered will enable the construction of a therapeutic education program for better patient care and to strengthen the patient's capacities so that he becomes an actor in his change throughout his care project.
This a 3 steps study:
- 200 patients will be enrolled and answer a questionnaire on knowledge of the disease
- Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
- Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Limoges、フランス、87042
- Service d'Ophtalmologie
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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
説明
Inclusion Criteria:
- Patient with AMD (neovascular and atrophic) whatever the stage of the disease
- Patient over 50
- Patient affiliated to a social security scheme
- Written informed consent of the patient
Exclusion Criteria:
- Patient unable to understand the information, fill out the questionnaires
- Patient with diabetic retinopathy
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
- 主な目的:支持療法
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の:Assessment
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
|
informant-based questionnaire semi-structured individual interviews focus group interviews
|
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 |
|---|---|---|
|
Knowledge of AMD
時間枠:throughout the study, 2 years at maximum
|
Assesment concern patients knowledge of AMD disease, the treatment of AMD, the diagnostic of AMD and the knowledge on the AMD risk factors A 12 items standardised questionnaire will be used
|
throughout the study, 2 years at maximum
|
|
Social vulnerability
時間枠:throughout the study, 2 years at maximum
|
Assessed by EPICES scale (Evaluation of Precariousness and Health Inequalities in the Health Examination Centers).
It is an individual indicator of precariousness that takes into account the multidimensional nature of precariousness.
Compsed of 11 items .
4 unfavorable answers indicate a Social vulnerability
|
throughout the study, 2 years at maximum
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Health literacy.
時間枠:throughout the study, 2 years at maximum
|
Assessed by the Health Literacy Questionnaire (HLQ) scale. It has nine scales that each measure an aspect of the multidimensional construct of health literacy. Higher scores assess for an good health literacy |
throughout the study, 2 years at maximum
|
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 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- I16027/DEMELE
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。