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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)

24 mars 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Résilié

Les conditions

Type d'étude

Interventionnel

Inscription (Réel)

178

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Bordeaux, France
        • CHU Bordeaux
      • Brest, France
        • CHRU Brest
      • Lille, France
        • Groupe Hospitalier de L Institut Catholique de Lille
      • Lyon, France
        • Hospices Civils
      • Marseille, France
        • AP-HM
      • Montpellier, France
        • CHU Montpellier
      • Nancy, France
        • CHRU Nancy
      • Nantes, France
        • CHU Nantes
      • Nice, France
        • CHU Nice
      • Rennes, France
        • CHU Rennes
      • Toulouse, France
        • Chu Toulouse

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

3 mois à 18 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Contrôler
Expérimental: 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)
Autres noms:
  • within 2 weeks after session therapeutic education

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
difference in the area under the curve of SCORAD
Délai: Week 0, week 4, week 12 and week 24
Week 0, week 4, week 12 and week 24

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Directeur d'études: Sebastien BARBAROT, Dr, CHU Nantes

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2016

Achèvement primaire (Réel)

1 mars 2021

Achèvement de l'étude (Réel)

1 mars 2021

Dates d'inscription aux études

Première soumission

16 décembre 2015

Première soumission répondant aux critères de contrôle qualité

16 décembre 2015

Première publication (Estimation)

18 décembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mars 2022

Dernière vérification

1 avril 2021

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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