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.
研究概览
研究类型
介入性
注册 (实际的)
178
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Bordeaux、法国
- CHU Bordeaux
-
Brest、法国
- CHRU Brest
-
Lille、法国
- Groupe Hospitalier de L Institut Catholique de Lille
-
Lyon、法国
- Hospices Civils
-
Marseille、法国
- AP-HM
-
Montpellier、法国
- CHU Montpellier
-
Nancy、法国
- CHRU NANCY
-
Nantes、法国
- CHU Nantes
-
Nice、法国
- CHU NICE
-
Rennes、法国
- Chu Rennes
-
Toulouse、法国
- CHU Toulouse
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
3个月 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：控制
|
|
|
实验性的：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.
|
within 2 weeks after inclusion (week 0)
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
difference in the area under the curve of SCORAD
大体时间：Week 0, week 4, week 12 and week 24
|
Week 0, week 4, week 12 and week 24
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD
大体时间：weekly during 24 weeks
|
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)
|
weekly during 24 weeks
|
|
difference in disease severity measured, throughout the study by EASI
大体时间：Week 0, week 4, week 12 and week 24
|
To assess the impact of a nurses-led TPE program on AD severity measured by the Eczema Area and Severity Index (EASI)
|
Week 0, week 4, week 12 and week 24
|
|
difference in quality of life of the child, measured throughout the study using an age appropriate score
大体时间：Week 0, week 4, week 12 and week 24
|
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
|
|
difference in adherence to treatment measured throughout the study with the VAS scale
大体时间：Week 0, week 4, week 12 and week 24
|
To assess the impact of a nurses-led TPE program on Adherence to topical anti-inflammatory treatments
|
Week 0, week 4, week 12 and week 24
|
|
difference in patients/parents satisfaction assessed by a Likert scale
大体时间：at week 24
|
To assess the impact of a nurses-led TPE program on Parents/patients satisfaction
|
at week 24
|
|
difference in corticosteroid phobia measured by TOPICOP score
大体时间：Week 0, week 4, week 12 and week 24
|
To assess the impact of a nurses-led TPE program on corticophobia
|
Week 0, week 4, week 12 and week 24
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Sebastien BARBAROT, Dr、CHU Nantes
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年2月1日
初级完成 (实际的)
2021年3月1日
研究完成 (实际的)
2021年3月1日
研究注册日期
首次提交
2015年12月16日
首先提交符合 QC 标准的
2015年12月16日
首次发布 (估计)
2015年12月18日
研究记录更新
最后更新发布 (实际的)
2022年3月25日
上次提交的符合 QC 标准的更新
2022年3月24日
最后验证
2021年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.