Validation of the Paediatric Electronic quality of Life Instrument for Childhood Asthma in the Netherlands.

• Conditions: asthma; bronchial asthma; 10006436

• Registration Number: NL-OMON32237
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 275

Inclusion Criteria

For the asthmatic children
* age 4 to 12 years
* signed informed consent by parent (or caretaker)
* child agrees to participate in the study
* at least two prescriptions for inhaled asthma medication during the previous year
* use of inhaled asthma medication for at least six weeks during the previous year
* physician-diagnosed asthma (a symptom diagnose asthma by a physician in case the child is 4 or 5 years old ) ;For the healthy individuals (reference population)
* age 6 to 12 years
* signed informed consent by parents (or caretakers)
* child agrees to participate in the study

Exclusion Criteria

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Pelican instrument should have the following (clinimetric) characteristics:<br /><br>has a high internal consistency and is able to detect relevant changes in HRQL<br /><br>within an individual child aged 6 to 12 years (evaluative capacity of the<br /><br>instrument). Moreover, the validity of the individualised part of the<br /><br>instrument should be good and the instrument is comprehendible, serviceableness<br /><br>and acceptable according to the children.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Pelican instrument should have the following (clinimetric) characteristics:<br /><br>is able to discriminate between relevant groups; is valid based on<br /><br>cross-sectional construct validity; is reliable and valid for children with<br /><br>asthma aged 4 or 5. Next the influence of a reminder on the reliability of the<br /><br>children*s answers will be evaluated. </p><br>