title: PELICAN: A quality of life instrument for childhood asthma: study protocol of two randomized controlled trials in primary and specialized care in the Netherlands.
abstract: BACKGROUND
  Asthma is one of the major chronic health problems in children in the Netherlands. The Pelican is a paediatric asthma-related quality of life instrument for children with asthma from 6-11 years old, which is suitable for clinical practice in primary and specialized care. Based on this instrument, we developed a self-management treatment to improve asthma-related quality of life. The Pelican intervention will be investigated in different health care settings. Results of intervention studies are often extrapolated to other health care settings than originally investigated. Because of differences in organization, disease severity, patient characteristics and care provision between health care settings, extrapolating research results could lead to unnecessary health costs without the desired health care achievements. Therefore, interventions have to be investigated in different health care settings when possible. This study is an example of an intervention study in different health care settings. In this article, we will present the study protocol of the Pelican study in primary and specialized care.
  
  
  METHODS
  This study consists of two randomized controlled trials to assess the effectiveness of the Pelican intervention in primary and specialized care. The trial in primary care is a multilevel design with 170 children with asthma in 16 general practices. All children in one general practices are allocated to the same treatment group. The trial in specialized care is a multicentre trial with 100 children with asthma. Children in one outpatient clinic are randomly allocated to the intervention or usual care group. In both trials, children will visit the care provider four times during a follow-up of nine months. This study is registered and ethically approved.
  
  
  CONCLUSIONS
  This article describes the study protocol of the Pelican study in different health care settings. If the Pelican intervention proves to be effective and efficient, implementation in primary and specialized care for paediatric asthma in the Netherlands will be recommended.
  
  
  BACKGROUND
  This study is registered by clinicaltrial.gov (NCT01109745).
authors.affiliation: Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, The Netherlands. s.vanbragt@elg.umcn.nl
authors.forename: Stephanie
authors.initials: S
authors.lastname: van Bragt
authors.forename: Lisette
authors.initials: L
authors.lastname: van den Bemt
authors.forename: Bart
authors.initials: B
authors.lastname: Thoonen
authors.forename: Chris
authors.initials: C
authors.lastname: van Weel
authors.forename: Peter
authors.initials: P
authors.lastname: Merkus
authors.forename: Tjard
authors.initials: T
authors.lastname: Schermer
mesh_terms: D001249:Asthma / Q000191:economics / Q000628:therapy*; D002648:Child; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005500:Follow-Up Studies; D006305:Health Status Indicators; D006801:Humans; D009426:Netherlands; D010043:Outcome and Process Assessment, Health Care; D018579:Patient Selection; D011320:Primary Health Care / Q000191:economics; D011788:Quality of Life; D018401:Sample Size; D063127:Secondary Health Care / Q000191:economics; D012648:Self Care / Q000191:economics / Q000379:methods*; D011795:Surveys and Questionnaires