NCT02634905

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 25, 2022

Status Verified

April 1, 2021

Enrollment Period

5.1 years

First QC Date

December 16, 2015

Last Update Submit

March 24, 2022

Conditions

Dermatitis, Atopic

Keywords

atopic dermatitisTherapeutic patient educationpediatric dermatology

Outcome Measures

Primary Outcomes (1)

  • difference in the area under the curve of SCORAD

    Week 0, week 4, week 12 and week 24

Secondary Outcomes (6)

  • difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD

    weekly during 24 weeks

  • difference in disease severity measured, throughout the study by EASI

    Week 0, week 4, week 12 and week 24

  • difference in quality of life of the child, measured throughout the study using an age appropriate score

    Week 0, week 4, week 12 and week 24

  • difference in adherence to treatment measured throughout the study with the VAS scale

    Week 0, week 4, week 12 and week 24

  • difference in patients/parents satisfaction assessed by a Likert scale

    at week 24

  • +1 more secondary outcomes

Study Arms (2)

Individual session therapeutic education

EXPERIMENTAL

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 educationOther: Phone Call

Control

NO INTERVENTION

Interventions

Individual session therapeutic educationOTHER

within 2 weeks after inclusion (week 0)

Individual session therapeutic education
Phone CallOTHER
Also known as: within 2 weeks after session therapeutic education
Individual session therapeutic education

Eligibility Criteria

Age3 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Chu Bordeaux

Bordeaux, France

Location

Chru Brest

Brest, France

Location

Groupe Hospitalier de L Institut Catholique de Lille

Lille, France

Location

Hospices Civils

Lyon, France

Location

AP-HM

Marseille, France

Location

Chu Montpellier

Montpellier, France

Location

Chru Nancy

Nancy, France

Location

Chu Nantes

Nantes, France

Location

CHU NICE

Nice, France

Location

Chu Rennes

Rennes, France

Location

Chu Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sebastien BARBAROT, Dr

    Nantes University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 18, 2015

Study Start

February 1, 2016

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

March 25, 2022

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)