NCT02634905

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

* 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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
OTHER	Individual session therapeutic education	within 2 weeks after inclusion (week 0)
OTHER	Phone Call

Timeline

• Start date: 2016-02-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2015-12-18
• Last updated: 2022-03-25

Locations

11 sites across 1 country: France