Title
Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): Study protocol for a pragmatic randomized controlled trial (DAVOS trial)
Author
Fieten, K.B.
Zijlstra, W.T.
van Os-Medendorp, H.
Meijer, Y.
Venema, M.U.
Rijssenbeek-Nouwens, L.
l' Hoir, M.P.
Bruijnzeel-Koomen, C.A.
Pasmans, S.G.M.A.
Publication year
2014
Abstract
Background: About 10 to 20% of children in West European countries have atopic dermatitis (AD), often as part of the atopic syndrome. The full atopic syndrome also consists of allergic asthma, allergic rhinitis and food allergy. Treatment approaches for atopic dermatitis and asthma include intermittent anti-inflammatory therapy with corticosteroids, health education and self-management training. However, symptoms persist in a subgroup of patients. Several observational studies have shown significant improvement in clinical symptoms in children and adults with atopic dermatitis or asthma after treatment at high altitude, but evidence on the efficacy when compared to treatment at sea level is still lacking.Methods/Design: This study is a pragmatic randomized controlled trial for children with moderate to severe AD within the atopic syndrome. Patients are eligible for enrolment in the study if they are: diagnosed with moderate to severe AD within the atopic syndrome, aged between 8 and 18 years, fluent in the Dutch language, have internet access at home, able to use the digital patient system Digital Eczema Center Utrecht (DECU), willing and able to stay in Davos for a six week treatment period. All data are collected at the Wilhelmina Children's Hospital and DECU. Patients are randomized over two groups. The first group receives multidisciplinary inpatient treatment during six weeks at the Dutch Asthma Center in Davos, Switzerland. The second group receives multidisciplinary treatment during six weeks at the outpatient clinic of the Wilhelmina Children's Hospital, Utrecht, the Netherlands. The trial is not conducted as a blind trial. The trial is designed with three components: psychosocial, clinical and translational. Primary outcomes are coping with itch, quality of life and disease activity. Secondary outcomes include asthma control, medication use, parental quality of life, social and emotional wellbeing of the child and translational parameters.Discussion: The results of this trial will provide evidence for the efficacy of high altitude treatment compared to treatment at sea level for children with moderate to severe AD.Trial Registration: Current Controlled Trials ISRCTN88136485. © 2014 Fieten et al.; licensee BioMed Central Ltd.
Subject
ELSS - Earth, Life and Social Sciences
Behavioural Changes
Healthy Living
Healthy for Life
Asthma
Atopic dermatitis
Atopic eczema
Atopic syndrome
Children
Coping
High altitude treatment
Multidisciplinary treatment
Quality of life
RCT
Adult
Altitude
Coping behavior
Corticosteroid therapy
Disease activity
Disease control
Health education
Human
Intermethod comparison
Medical care
Netherlands
Outpatient department
Physical activity
Pruritus
Randomized controlled trial
School child
Sea level
Self care
Sleep disorder
Switzerland
Treatment duration
Wellbeing
CH - Child Health
To reference this document use:
http://resolver.tudelft.nl/uuid:70b1670f-2fb2-449e-ac7b-844affb0890d
DOI
https://doi.org/10.1186/1745-6215-15-94
TNO identifier
500224
ISSN
1745-6215
Source
Trials, 15 (15)
Document type
article