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 maart 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
178
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Bordeaux, Frankrijk
- CHU Bordeaux
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Brest, Frankrijk
- CHRU Brest
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Lille, Frankrijk
- Groupe Hospitalier de L Institut Catholique de Lille
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Lyon, Frankrijk
- Hospices Civils
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Marseille, Frankrijk
- AP-HM
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Montpellier, Frankrijk
- CHU Montpellier
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Nancy, Frankrijk
- CHRU NANCY
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Nantes, Frankrijk
- CHU Nantes
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Nice, Frankrijk
- CHU NICE
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Rennes, Frankrijk
- Chu Rennes
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Toulouse, Frankrijk
- CHU Toulouse
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
3 maanden tot 18 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: Controle
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Experimenteel: 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)
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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difference in the area under the curve of SCORAD
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Sebastien BARBAROT, Dr, CHU Nantes
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 februari 2016
Primaire voltooiing (Werkelijk)
1 maart 2021
Studie voltooiing (Werkelijk)
1 maart 2021
Studieregistratiedata
Eerst ingediend
16 december 2015
Eerst ingediend dat voldeed aan de QC-criteria
16 december 2015
Eerst geplaatst (Schatting)
18 december 2015
Updates van studierecords
Laatste update geplaatst (Werkelijk)
25 maart 2022
Laatste update ingediend die voldeed aan QC-criteria
24 maart 2022
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RC15_0035
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
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