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)
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|ClinicalTrials.gov Identifier: NCT02634905|
Recruitment Status : Terminated (end of recruitment)
First Posted : December 18, 2015
Last Update Posted : April 22, 2021
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Other: Individual session therapeutic education Other: Phone Call||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||March 2021|
|Actual Study Completion Date :||March 2021|
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.
Other: Individual session therapeutic education
within 2 weeks after inclusion (week 0)
Other: Phone Call
Other Name: within 2 weeks after session therapeutic education
|No Intervention: Control|
- difference in the area under the curve of SCORAD [ Time Frame: Week 0, week 4, week 12 and week 24 ]
- difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD [ Time Frame: 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)
- difference in disease severity measured, throughout the study by EASI [ Time Frame: 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)
- difference in quality of life of the child, measured throughout the study using an age appropriate score [ Time Frame: 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)
- difference in adherence to treatment measured throughout the study with the VAS scale [ Time Frame: 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
- difference in patients/parents satisfaction assessed by a Likert scale [ Time Frame: at week 24 ]To assess the impact of a nurses-led TPE program on Parents/patients satisfaction
- difference in corticosteroid phobia measured by TOPICOP score [ Time Frame: Week 0, week 4, week 12 and week 24 ]To assess the impact of a nurses-led TPE program on corticophobia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02634905
|Groupe Hospitalier de L Institut Catholique de Lille|
|Study Director:||Sebastien BARBAROT, Dr||CHU Nantes|