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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 (EDUDA)

Primary Purpose

Dermatitis, Atopic

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Individual session therapeutic education
Phone Call
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dermatitis, Atopic focused on measuring atopic dermatitis, Therapeutic patient education, pediatric dermatology

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chu Bordeaux
  • Chru Brest
  • Groupe Hospitalier de L Institut Catholique de Lille
  • Hospices Civils
  • AP-HM
  • Chu Montpellier
  • Chru Nancy
  • Chu Nantes
  • CHU NICE
  • Chu Rennes
  • Chu Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Individual session therapeutic education

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

difference in the area under the curve of SCORAD

Secondary Outcome Measures

difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD
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
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
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
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
To assess the impact of a nurses-led TPE program on Parents/patients satisfaction
difference in corticosteroid phobia measured by TOPICOP score
To assess the impact of a nurses-led TPE program on corticophobia

Full Information

First Posted
December 16, 2015
Last Updated
March 24, 2022
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02634905
Brief 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
Acronym
EDUDA
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
end of recruitment
Study Start Date
February 2016 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
atopic dermatitis, Therapeutic patient education, pediatric dermatology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individual session therapeutic education
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Individual session therapeutic education
Intervention Description
within 2 weeks after inclusion (week 0)
Intervention Type
Other
Intervention Name(s)
Phone Call
Other Intervention Name(s)
within 2 weeks after session therapeutic education
Primary Outcome Measure Information:
Title
difference in the area under the curve of SCORAD
Time Frame
Week 0, week 4, week 12 and week 24
Secondary Outcome Measure Information:
Title
difference in the self-assessed long term control of disease severity measured by the area under the curve of the performed PO-SCORAD
Description
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)
Time Frame
weekly during 24 weeks
Title
difference in disease severity measured, throughout the study by EASI
Description
To assess the impact of a nurses-led TPE program on AD severity measured by the Eczema Area and Severity Index (EASI)
Time Frame
Week 0, week 4, week 12 and week 24
Title
difference in quality of life of the child, measured throughout the study using an age appropriate score
Description
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)
Time Frame
Week 0, week 4, week 12 and week 24
Title
difference in adherence to treatment measured throughout the study with the VAS scale
Description
To assess the impact of a nurses-led TPE program on Adherence to topical anti-inflammatory treatments
Time Frame
Week 0, week 4, week 12 and week 24
Title
difference in patients/parents satisfaction assessed by a Likert scale
Description
To assess the impact of a nurses-led TPE program on Parents/patients satisfaction
Time Frame
at week 24
Title
difference in corticosteroid phobia measured by TOPICOP score
Description
To assess the impact of a nurses-led TPE program on corticophobia
Time Frame
Week 0, week 4, week 12 and week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien BARBAROT, Dr
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chu Bordeaux
City
Bordeaux
Country
France
Facility Name
Chru Brest
City
Brest
Country
France
Facility Name
Groupe Hospitalier de L Institut Catholique de Lille
City
Lille
Country
France
Facility Name
Hospices Civils
City
Lyon
Country
France
Facility Name
AP-HM
City
Marseille
Country
France
Facility Name
Chu Montpellier
City
Montpellier
Country
France
Facility Name
Chru Nancy
City
Nancy
Country
France
Facility Name
Chu Nantes
City
Nantes
Country
France
Facility Name
CHU NICE
City
Nice
Country
France
Facility Name
Chu Rennes
City
Rennes
Country
France
Facility Name
Chu Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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