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 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
178
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Bordeaux, Frankrike
- CHU Bordeaux
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Brest, Frankrike
- CHRU Brest
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Lille, Frankrike
- Groupe Hospitalier de L Institut Catholique de Lille
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Lyon, Frankrike
- Hospices Civils
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Marseille, Frankrike
- AP-HM
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Montpellier, Frankrike
- CHU Montpellier
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Nancy, Frankrike
- CHRU NANCY
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Nantes, Frankrike
- CHU Nantes
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Nice, Frankrike
- CHU NICE
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Rennes, Frankrike
- Chu Rennes
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Toulouse, Frankrike
- CHU Toulouse
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
3 månader till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: Kontrollera
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Experimentell: 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)
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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difference in the area under the curve of SCORAD
Tidsram: Week 0, week 4, week 12 and week 24
|
Week 0, week 4, week 12 and week 24
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: 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
Tidsram: 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)
|
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
Tidsram: 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
Tidsram: 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
|
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difference in patients/parents satisfaction assessed by a Likert scale
Tidsram: at week 24
|
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
Tidsram: 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
|
Week 0, week 4, week 12 and week 24
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Sebastien BARBAROT, Dr, CHU Nantes
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2016
Primärt slutförande (Faktisk)
1 mars 2021
Avslutad studie (Faktisk)
1 mars 2021
Studieregistreringsdatum
Först inskickad
16 december 2015
Först inskickad som uppfyllde QC-kriterierna
16 december 2015
Första postat (Uppskatta)
18 december 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 mars 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 mars 2022
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RC15_0035
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
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