Clinical trial NCT02634905: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Therapeutic patient education
pediatric dermatology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 178
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: * 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.


Eligibility criteria: 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.

Primary outcomes:
measure: difference in the area under the curve of SCORAD
timeFrame: Week 0, week 4, week 12 and week 24
Secondary outcomes:
measure: difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD
timeFrame: weekly during 24 weeks
measure: difference in disease severity measured, throughout the study by EASI
timeFrame: Week 0, week 4, week 12 and week 24
measure: difference in quality of life of the child, measured throughout the study using an age appropriate score
timeFrame: Week 0, week 4, week 12 and week 24
measure: difference in adherence to treatment measured throughout the study with the VAS scale
timeFrame: Week 0, week 4, week 12 and week 24
measure: difference in patients/parents satisfaction assessed by a Likert scale
timeFrame: at week 24
measure: difference in corticosteroid phobia measured by TOPICOP score
timeFrame: Week 0, week 4, week 12 and week 24
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Brest
country: France
facility: Chru Brest
city: Lille
country: France
facility: Groupe Hospitalier de L Institut Catholique de Lille
city: Lyon
country: France
facility: Hospices Civils
city: Marseille
country: France
facility: AP-HM
city: Montpellier
country: France
facility: Chu Montpellier
city: Nancy
country: France
facility: Chru Nancy
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: CHU NICE
city: Rennes
country: France
facility: Chu Rennes
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: Nantes University Hospital
name: Sebastien BARBAROT, Dr
role: STUDY_DIRECTOR
References: