PELICAN: A quality of life instrument for childhood asthma: Study Protocol of two Randomized Controlled Trials in Primary and Specialized Care in the Netherlands

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.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.This study is registered by clinicaltrial.gov (NCT01109745)Asthma [1] is the most common chronic disease in childhood in the Netherlands. Its prevalence ranges from 3% in children aged 5–9？years to 3.7% in children aged 10–14？years [2,3]. Although the prevalence is leveling off [4], asthma remains a significant burden for the child, family and the society at large [5]. In the Netherlands, children with intermittent and mild asthma are usually treated by a family physician, while patients with more severe or uncontrolled asthma are treated by specialized paediatric care [6]. This implies that children with asthma treated in primary and specialized care may differ in features like disease severity and complexity, level of symptom control, functional status and co-morbidity [7]. Recent reports point to substantial room for improvement in the management of childhood asthma [8-11]. Poor adherence to therapy and inadequately treatment are two important reasons why asthma is uncontrolled [9]. Poor adherence has been associated with discrepancies between the p