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

NCT ID: NCT02634905

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2021-03-31

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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Individual session therapeutic education

Intervention Type: OTHER

within 2 weeks after inclusion (week 0)

Phone Call

Intervention Type: OTHER

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Individual session therapeutic education

within 2 weeks after inclusion (week 0)

Intervention Type: OTHER

Phone Call

Intervention Type: OTHER

Other Intervention Names

within 2 weeks after session therapeutic education

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastien BARBAROT, Dr

Role: STUDY_DIRECTOR

Nantes University Hospital

Locations

Chu Bordeaux

Bordeaux, , France

Chru Brest

Brest, , France

Groupe Hospitalier de L Institut Catholique de Lille

Lille, , France

Hospices Civils

Lyon, , France

AP-HM

Marseille, , France

Chu Montpellier

Montpellier, , France

Chru Nancy

Nancy, , France

Chu Nantes

Nantes, , France

CHU NICE

Nice, , France

Chu Rennes

Rennes, , France

Chu Toulouse

Toulouse, , France

Countries

France

Other Identifiers

RC15_0035

Identifier Type: -

Identifier Source: org_study_id