Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02634905
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Other: Individual session therapeutic education Other: Phone Call Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
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
Study Start Date : February 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. difference in the area under the curve of SCORAD [ Time Frame: Week 0, week 4, week 12 and week 24 ]

Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)


  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Sebastien BARBAROT sebastien.barbarot@chu-nantes.fr

Locations
Layout table for location information
France
Chu Bordeaux Recruiting
Bordeaux, France
Principal Investigator: FRANCK BORALEVI         
Chru Brest Recruiting
Brest, France
Principal Investigator: Laurent MISERY         
Groupe Hospitalier de L Institut Catholique de Lille Recruiting
Lille, France
Principal Investigator: AUDREY LASEK         
Hospices Civils Recruiting
Lyon, France
Principal Investigator: ALICE PHAN         
AP-HM Recruiting
Marseille, France
Principal Investigator: STEPHANIE MALLET         
Chu Montpellier Recruiting
Montpellier, France
Principal Investigator: NADIA RAISON         
Chru Nancy Recruiting
Nancy, France
Principal Investigator: Anne-Claire Bursztejn         
Chu Nantes Recruiting
Nantes, France
Principal Investigator: SEBASTIEN BARBAROT         
CHU NICE Active, not recruiting
Nice, France
Chu Rennes Recruiting
Rennes, France
Principal Investigator: CATHERINE DROITCOURT         
Chu Toulouse Recruiting
Toulouse, France
Principal Investigator: JULIETTE MAZEREEUW HAUTIER         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Layout table for investigator information
Study Director: Sebastien BARBAROT, Dr CHU Nantes

Layout table for additonal information
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02634905     History of Changes
Other Study ID Numbers: RC15_0035
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nantes University Hospital:
atopic dermatitis
Therapeutic patient education
pediatric dermatology

Additional relevant MeSH terms:
Layout table for MeSH terms
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases