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 de marzo de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
178
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Bordeaux, Francia
- CHU Bordeaux
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Brest, Francia
- CHRU Brest
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Lille, Francia
- Groupe Hospitalier de L Institut Catholique de Lille
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Lyon, Francia
- Hospices Civils
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Marseille, Francia
- AP-HM
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Montpellier, Francia
- CHU Montpellier
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Nancy, Francia
- CHRU NANCY
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Nantes, Francia
- CHU Nantes
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Nice, Francia
- CHU NICE
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Rennes, Francia
- Chu Rennes
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Toulouse, Francia
- CHU Toulouse
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
3 meses a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Control
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Experimental: 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)
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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difference in the area under the curve of SCORAD
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Sebastien BARBAROT, Dr, CHU Nantes
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de febrero de 2016
Finalización primaria (Actual)
1 de marzo de 2021
Finalización del estudio (Actual)
1 de marzo de 2021
Fechas de registro del estudio
Enviado por primera vez
16 de diciembre de 2015
Primero enviado que cumplió con los criterios de control de calidad
16 de diciembre de 2015
Publicado por primera vez (Estimar)
18 de diciembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
24 de marzo de 2022
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RC15_0035
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
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