Clinical trial NCT01109745: Effectiveness of the Pelican Instrument in Medical Care
Official title: Effectiveness of the Paediatric Electronic Quality of Life Instrument for Childhood Asthma in the Netherlands (Pelican) in Medical Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
health-related quality of life
patient-centred care
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-04-23
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this project is to establish the effectiveness of implementation of a self-administered electronic asthma-specific quality of life instrument for childhood asthma in primary care and specialist care.

Detailed description: Health related quality of life (HRQL) is important to the asthmatic child and if HRQL aspects are taken into account in daily care this could result in improved treatment satisfaction, compliance, asthma control and, ultimately, improved HRQL. The Pelican instrument we have developed has the essential features to be useful in daily care. In this study, the effectiveness of implementing the Pelican instrument in medical care is assessed. An intervention study with 9 months follow-up in primary and secondary care will be carried out.

Eligibility criteria: Inclusion Criteria:

* age 6 to 12 years
* physician-diagnosed asthma
* use of bronchodilators and / or inhaled corticosteroids for at least six weeks during the previous year
* child is treated for its asthma by the recruiting physician
* signed informed consent by parent (or caretaker)
* child agrees to participate in the study

Exclusion Criteria:

* comorbid condition that significantly influences HRQL
* child does not master the Dutch language sufficiently
* not being able to attend a regular school class

Primary outcomes:
measure: quality of life
timeFrame: 9 months
Secondary outcomes:
measure: asthma control
timeFrame: 9 months
measure: Symptoms and medication
timeFrame: 9 months
measure: Lung function
timeFrame: 9 months
measure: Cost-effectiveness
timeFrame: 9 months
measure: caregiver quality of life
timeFrame: 9 months
measure: process-outcomes
timeFrame: 9 months
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: Brabant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Brabant
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
state: Zuid-Holland
city: 's Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Venlo
country: Netherlands
facility: Viecuri Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Lisette van den Bemt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Tjard RJ Schermer, PhD
role: STUDY_DIRECTOR
References:
citation: van den Bemt L, Kooijman S, Linssen V, Lucassen P, Muris J, Slabbers G, Schermer T. How does asthma influence the daily life of children? Results of focus group interviews. Health Qual Life Outcomes. 2010 Jan 14;8:5. doi: 10.1186/1477-7525-8-5.
citation: van Bragt S, van den Bemt L, Cretier R, van Weel C, Merkus P, Schermer T. PELICAN: Content evaluation of patient-centered care for children with asthma based on an online tool. Pediatr Pulmonol. 2016 Oct;51(10):993-1003. doi: 10.1002/ppul.23397. Epub 2016 Apr 29.
citation: van Bragt S, van den Bemt L, Thoonen B, van Weel C, Merkus P, Schermer T. PELICAN: A quality of life instrument for childhood asthma: study protocol of two randomized controlled trials in primary and specialized care in the Netherlands. BMC Pediatr. 2012 Aug 30;12:137. doi: 10.1186/1471-2431-12-137.