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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. marts 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

178

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

3 måneder til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Eksperimentel: 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.
Andet: Individual session therapeutic education
within 2 weeks after inclusion (week 0)
Andet: Phone Call
Andre navne:
  • within 2 weeks after session therapeutic education

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
difference in the area under the curve of SCORAD
Tidsramme: Week 0, week 4, week 12 and week 24
Week 0, week 4, week 12 and week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nantes University Hospital

Efterforskere

  • Studieleder: Sebastien BARBAROT, Dr, CHU Nantes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2016

Primær færdiggørelse (Faktiske)

1. marts 2021

Studieafslutning (Faktiske)

1. marts 2021

Datoer for studieregistrering

Først indsendt

16. december 2015

Først indsendt, der opfyldte QC-kriterier

16. december 2015

Først opslået (Skøn)

18. december 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2022

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RC15_0035

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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Kliniske forsøg med Dermatitis, atopisk

Kliniske forsøg med Individual session therapeutic education

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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