A Multicenter Randomized Control Trial in Children With Moderate to Severe Atopic Dermatitis to Assess the Benefit of a Nurse-led One-to-one Education Program in Addition to Standard Care Compared to Standard Care Alone on the Long Term Control of Disease Severity at 6 Months (EDUDA)
2022年3月24日 更新者：Nantes University Hospital
- Atopic dermatitis is a chronic relapsing disease, which is highly prevalent in children (15%). Therapeutic patient education (TPE) has been recognized as a key priority topic for future AD research. The strongest evidence in favour of TPE efficacy in AD comes from a large study assessing repeated multi-disciplinary group education sessions in a hospital setting. However, this type of intervention is both resource and time consuming and is not adapted to typical French practice. However, in some french dermatology centers, simple "first level" nurse-led TPE interventions are offered in addition to physicians consultations. Unfortunately, the content of these interventions seems to vary greatly depending on the caregiver and the center and the benefits of these practices have not yet been assessed. Therefore, nurse-led TPE is not considered as current care in France for AD patients.
- Thus, there is a need to rigorously assess the benefits of additional, well-structured, simple nurse-led individual TPE interventions for children with AD and their families compared to standard care alone. This study will be the first large, adequately powered, multicenter RCT trial assessing this type of intervention in children with AD.
調査の概要
研究の種類
介入
入学 (実際)
178
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
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Bordeaux、フランス
- CHU Bordeaux
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Brest、フランス
- CHRU Brest
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Lille、フランス
- Groupe Hospitalier de L Institut Catholique de Lille
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Lyon、フランス
- Hospices Civils
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Marseille、フランス
- AP-HM
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Montpellier、フランス
- CHU Montpellier
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Nancy、フランス
- CHRU NANCY
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Nantes、フランス
- CHU Nantes
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Nice、フランス
- CHU NICE
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Rennes、フランス
- Chu Rennes
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Toulouse、フランス
- CHU Toulouse
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
3ヶ月～18年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patient with AD, defined according to the criteria of the United Kingdom Working Party : AD should be diagnosed when a child has an itchy skin condition plus three or more of the following: Protocol EDU DA RC15_0035 Version n°4 du 15/09/16 Page 28 sur 44 CONFIDENTIAL Visible flexural dermatitis involving the skin creases, such as the bends of the elbows or behind the knees (or visible dermatitis on the cheeks and/or extensor areas in children aged under 10 years) Personal history of flexural dermatitis (or dermatitis on the cheeks and/or extensor areas in children under 10 years) Personal history of dry skin in the last 12 months Personal history of asthma or allergic rhinitis (or history of atopic disease in a firstdegree relative of children aged under 4 years)
- Onset of signs and symptoms under the age of 2 years (this criterion should not be used in children aged less than 4 years). Patient aged at least 3 months and less than 18 years.
- SCORAD 20 (moderate to severe AD)
- Patient who received treatment an anti-inflammatory topical treatment (topical corticosteroid or topical tacrolimus)
- Informed consent of parents
- Agreement of the child when appropriate
- Patient affiliated to French social security system
Exclusion Criteria:
- Patient does not meet the criteria of AD
- SCORAD < 20
- Patient aged 18 years or more
- Patient treated with oral corticosteroids currently or systemic immunosuppressant 2 months prior to the eligibility assessment
- Patients with primary immunodeficiency diseases.
- Consent not given
- Patient not affiliated to French social security system
- Patient with intercurrent disease, may be excluded if the investigator believes participation in the trial is not in the best interest of the patient
- Personal decision of the child or their parents not to be included
- Child and / or parents lack the mental capacity to give informed consent
- Child / Parents do not have a sufficient command of the French language for understanding TPE program.
- Patient or parent who has already received structured TPE for AD.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：コントロール
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実験的：Individual session therapeutic education
The children included in the active arm will undergo, along with their parents (by child's age and wish), a structured individual TPE session between W0 and W2.
This session will be conducted by the nurse trained in TPE.
The session will be one hour long.
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within 2 weeks after inclusion (week 0)
他の名前：
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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 |
時間枠 |
|---|---|
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difference in the area under the curve of SCORAD
時間枠：Week 0, week 4, week 12 and week 24
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Week 0, week 4, week 12 and week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD
時間枠：weekly during 24 weeks
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To assess the impact of a nurses-led TPE program on Self-assessed long term control of AD severity measured using a self-assessment severity score (PO-SCORAD : patient-oriented SCORAD)
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weekly during 24 weeks
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difference in disease severity measured, throughout the study by EASI
時間枠：Week 0, week 4, week 12 and week 24
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To assess the impact of a nurses-led TPE program on AD severity measured by the Eczema Area and Severity Index (EASI)
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Week 0, week 4, week 12 and week 24
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difference in quality of life of the child, measured throughout the study using an age appropriate score
時間枠：Week 0, week 4, week 12 and week 24
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To assess the impact of a nurses-led TPE program on Children and family quality of life. (Age appropriate score = IDLQI for children under 4 years old, CDLQI for children and adolescents between 4 and 18 years old) |
Week 0, week 4, week 12 and week 24
|
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difference in adherence to treatment measured throughout the study with the VAS scale
時間枠：Week 0, week 4, week 12 and week 24
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To assess the impact of a nurses-led TPE program on Adherence to topical anti-inflammatory treatments
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Week 0, week 4, week 12 and week 24
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difference in patients/parents satisfaction assessed by a Likert scale
時間枠：at week 24
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To assess the impact of a nurses-led TPE program on Parents/patients satisfaction
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at week 24
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difference in corticosteroid phobia measured by TOPICOP score
時間枠：Week 0, week 4, week 12 and week 24
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To assess the impact of a nurses-led TPE program on corticophobia
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Week 0, week 4, week 12 and week 24
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Sebastien BARBAROT, Dr、CHU Nantes
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年2月1日
一次修了 (実際)
2021年3月1日
研究の完了 (実際)
2021年3月1日
試験登録日
最初に提出
2015年12月16日
QC基準を満たした最初の提出物
2015年12月16日
最初の投稿 (見積もり)
2015年12月18日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月25日
QC基準を満たした最後の更新が送信されました
2022年3月24日
最終確認日
2021年4月1日
詳しくは
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