Top care for children with atopic dermatitis (and asthma) within the atopy syndroom, using the digital Eczema Centre WKZ- Dutch Asthma Centre Davos

Since 2000, care innovations have been taken place at the department of
dermatology and allergology of the Wilhelmina Children's Hospital (WKZ) of the
UMC Utrecht. Multidisciplianry care have been developed for children with
atopic dermatitis, which is part of the atopy syndrome, and their parents. Last
years, we achieved good clinical results in children with atopic dermatitis and
asthma who were treated in the Dutch Athma Centre in Davos, Switzerland.
Carrying out this reserach proposal, we will support the clinical findings with
research evidence. The Digital Eczema Centre Utrecht will be used to optimalize
the collaboration between the WKZ and the NAD.

The primary research question is:
Do children with atopic dermatitis and asthma after a stay in the NAD have a
better coping and acceptance of their disease as compared with children treated
at the outpatient department of the WKZ?
Secondary research questions:
Have children with atopic dermatitis and asthma after a stay in the NAD as
compared with children treated at the outpatient department of the WKZ :
- less severe and extended eczema
- less severe asthma
- better self-esteem and feelings of competency
- more autonomy (for children of 12 years up)
- less anxiety
- higher asthma -specific quality of life
Have parents of children with atopic dermatitis and asthma after a stay in the
NAD as compared with parents of children treated at the outpatient department
of the WKZ
- less stress
- less anxiety
- a higher disease-specific quality of life

Secundary research questions that will be investigated in the translational
study:

Are there specific immunological markers in children with severe atopic
dermatitis and asthma that may predict the (long term) effect of a stay at the
NAD?
a. Is the response to treatment at the NAD associated with changes in the level
of FeNO and NO?
b. Is the response to treatment at the NAD associated with changes in the level
of expressed cytokines (OPN, TSLP and Th1/Th2 cytokines)?
c. Is the activity of atopic dermatitis associated with the level and diversity
of specific IgE to (auto)allergens?
d. Is the activity of atopic dermatitis associated with a differential
bacterial colonization of the skin and the nose?
e. Is the severity of eczema associated with the amount of TSLP and with
protease activity in the superficial skin?
f. Is the severity of eczema associated with an increased frequency of the TSLP
polymorphism SNP rs3806933 (-847C>T) as compared to healthy controls?

Secundary research questions that will be investigated in this second amendment:

g. Is there a relation between the severity of atopic dermatitis and bacterial
colonization of skin versus nose?
h. Is the severity of atopic dermatitis related to filaggrin mutations?
i. Are filaggrin mutations related to protease activity and/or bacterial
colonization of the skin?
j. Are filaggrin mutations related to TSLP polymorphism?
k. Are the translational research parameters related to the parameters from the
medical and psychological records?

Randomized controlled design, randomization after the initial multidisciplinary
treatment in the WKZ; Intervention group: stay in the NAD, control group:
intensive multidisciplinary treatment at the outpatient department of the
dermatology and allergology WKZ.

Before the start of the study:
All children will be treated by a dermatologist and a dermatology nurse in two
or three consultations in the WKZ/UMC Utrecht. Besides: all children have
access to the Digital Eczema Centre Utrecht for e-consult, monitoring and
online information focussed on adequate self-management. After that an
evaluation will take place, directed on physical and psychosocial complaints.
Children who fulfill the inclusion critera will be informed about the study by
a member of the multidisciplinary team, using oral and written information.
The intervention:
After signing the informend consent, the child will be discussed in the digital
multidisciplinary meeting of the WKZ and NAD teams. A treamtent plan will be
noted.
After that, randomization will take place for the intervention group:
hospitalization in the NAD or control group: treatment in out-patient clinic of
the WKZ.

In both, the NAD and WKZ, the child will be treated by a multidisciplinary
team, focussed on adequate self management. The care programme in both
hospitals consists of medical treatment, information and training focussed on
coping with eczema and asthma, recognizing symptoms, coping with constraints
and using possibilities in daily life. All children and their parents can use
the Digital Eczema Centre Utrecht during their stay in the NAD or treatment in
the WKZ.

I: treatment in the WKZ: Children will be treated for 6 weeks by a
multidisciplinary team at the outpatient department of
the WKZ. The child stays at home and exercise all skills in his own, familiar
environment.
II: stay in the NAD: Children will stay for 6 weeks in the NAD and lives
temporarily separate from his parents. School also takes place in the NAD. The
child exercise his skills in a new environment (also psycho-social). The NAD is
a high mountain hospital at 1600 metres above sea level with a less load of
airborne-allergens, infectious agents and environmental pollutants.

All children will be discussed during regulary digital meetings by teams of the
WKZ and NAD.
After six weeks, treatment will be continued at the dermatology outpatient
department of the WKZ.

The burden of the study consist of a face-to-face inclusion consultation of
thirty minutes. Questionnaires can be filled in in sixty minutes, five times
during the study. There are no risks associated with participation.

TARC will be determined as indicator of the severity of the eczema. This will
be combined with the usual VP, which is necessary for the diagnosis of
allergens. Pain during the VP will be minimilezed using analgetic patches.

The severity of asthma will be determined using a lung-function examination.
This examination will be carried out during usual control moments with the
pediatrician in the WKZ or NAD.

For the translational part that is added to this study, an extra VP and lung
function test is planned 6 weeks after treatment in the WKZ or NAD, to
determine the short-term effect of the treatment.