* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
178
within 2 weeks after inclusion (week 0)
Chu Bordeaux
Bordeaux, France
Chru Brest
Brest, France
Groupe Hospitalier de L Institut Catholique de Lille
Lille, France
Hospices Civils
Lyon, France
AP-HM
Marseille, France
Chu Montpellier
Montpellier, France
Chru Nancy
Nancy, France
Chu Nantes
Nantes, France
CHU NICE
Nice, France
Chu Rennes
Rennes, France
...and 1 more locations
difference in the area under the curve of SCORAD
Time frame: Week 0, week 4, week 12 and week 24
difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD
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)
Time frame: weekly during 24 weeks
difference in disease severity measured, throughout the study by EASI
To assess the impact of a nurses-led TPE program on AD severity measured by the Eczema Area and Severity Index (EASI)
Time frame: 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
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)
Time frame: Week 0, week 4, week 12 and week 24
difference in adherence to treatment measured throughout the study with the VAS scale
To assess the impact of a nurses-led TPE program on Adherence to topical anti-inflammatory treatments
Time frame: Week 0, week 4, week 12 and week 24
difference in patients/parents satisfaction assessed by a Likert scale
To assess the impact of a nurses-led TPE program on Parents/patients satisfaction
Time frame: at week 24
difference in corticosteroid phobia measured by TOPICOP score
To assess the impact of a nurses-led TPE program on corticophobia
Time frame: Week 0, week 4, week 12 and week 24
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