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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

NCT02634905 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2022-03-25

No results posted yet for this study

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

OTHER

Individual session therapeutic education

within 2 weeks after inclusion (week 0)

OTHER

Phone Call

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Sebastien BARBAROT, Dr · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2021-03-31
Completion
2021-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02634905 on ClinicalTrials.gov