Dermatitis, AtopicEDUDANCT02634905
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
A study testing Individual session therapeutic education and Phone Call in people with Dermatitis, Atopic, run by Nantes University Hospital at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Dermatitis, Atopic
- What is being tested?
- Individual session therapeutic education and Phone Call
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 11 sitesFrance
- Study dates
- Feb 2016to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Chu Bordeaux
Bordeaux
Chru Brest
Brest
Groupe Hospitalier de L Institut Catholique de Lille
Lille
Hospices Civils
Lyon
AP-HM
Marseille
Chu Montpellier
Montpellier
Chru Nancy
Nancy
Chu Nantes
Nantes
CHU NICE
Nice
Chu Rennes
Rennes
Chu Toulouse
Toulouse
About this study
- 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
- Being tested
- Individual session therapeutic education, Phone Call
- Keywords
- atopic dermatitis, Therapeutic patient education, pediatric dermatology
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual session therapeutic educationOther
within 2 weeks after inclusion (week 0)
Phone CallOther
Also called within 2 weeks after session therapeutic education
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Individual session therapeutic education; Other: Phone Call |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in the area under the curve of SCORAD
Measured: 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
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)
Measured: weekly during 24 weeks
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)
Measured: 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
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)
Measured: Week 0, week 4, week 12 and week 24
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
Measured: Week 0, week 4, week 12 and week 24
difference in patients/parents satisfaction assessed by a Likert scale
To assess the impact of a nurses-led TPE program on Parents/patients satisfaction
Measured: at week 24
difference in corticosteroid phobia measured by TOPICOP score
To assess the impact of a nurses-led TPE program on corticophobia
Measured: Week 0, week 4, week 12 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionMar 2021
- Study completionMar 2021
Why it stopped: end of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien BARBAROT, Dr, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634905
- Sponsor's protocol ID
- RC15_0035
- Acronym
- EDUDA
- Status last verified
- Apr 2021
- First submitted
- 16 Dec 2015
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02634905
- Acronym / sponsor ID
- EDUDA / RC15_0035
- Conditions
- Dermatitis, Atopic
- Keywords
- atopic dermatitis, Therapeutic patient education, pediatric dermatology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of recruitment
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual session therapeutic education | Experimental | Other: Individual session therapeutic education, Other: Phone CallThe 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individual session therapeutic educationwithin 2 weeks after inclusion (week 0) | Other | Individual session therapeutic education |
| Phone CallAlso: within 2 weeks after session therapeutic education | Other | Individual session therapeutic education |
Primary outcome
difference in the area under the curve of SCORAD
Time frame: Week 0, week 4, week 12 and week 24
6 secondary outcomes
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
difference in disease severity measured, throughout the study by EASI
Time frame: 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
Time frame: Week 0, week 4, week 12 and week 24
difference in adherence to treatment measured throughout the study with the VAS scale
Time frame: Week 0, week 4, week 12 and week 24
difference in patients/parents satisfaction assessed by a Likert scale
Time frame: at week 24
difference in corticosteroid phobia measured by TOPICOP score
Time frame: Week 0, week 4, week 12 and week 24
Results and safety
The study was stopped early (reason given: end of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien BARBAROT, Dr study director
Nantes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual session therapeutic education and Phone Call in people with Dermatitis, Atopic, run by Nantes University Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: end of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in the area under the curve of SCORAD (time frame: Week 0, week 4, week 12 and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.