AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood

Completed

• Conditions: Healthy

• Registration Number: NCT03286894
• Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

Brief Summary

The AQUA© questionnaire developed in 2008 is a validated tools for the screening of allergic diseases in adult athletes. The objective of the present study is to develop and validate a modified version of the AQUA© questionnaire to be used in childhood. In this phase, the validation is intended to assess the reliability of the information collected through the AQUA© modified version: question difficulty and response patterns with respect to children characteristics (in particular age, sex and physical activity). In particular, the focus will be on the "core questions", i.e. the indicators of allergic disorders. This is a cross-sectional study on 1264 healthy schoolchildren aged 8 to 14 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-19
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1264

Inclusion Criteria

• Aforementioned sex and age criteria.

Exclusion Criteria

• Respiratory infections in the previous 3 weeks;
• Immunological or metabolic systemic disease;
• Major malformations of the upper airways;
• Active smoker.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Question difficulty	Study end (4 months)	Comprehensibility (or difficulty) of the questions, especially the "core questions", will be assessed by the percentages of non-response possibly stratified by children characteristics (in particular age, sex and physical activity).

Secondary Outcome Measures

Name	Time	Method
Patterns of non-missing responses	Study end (4 months)	Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity).
Patterns of missing response	Study end (4 months)	Possible tendency to skip consecutive questions will be assessed by studying the association between the presence of missing (0 = answer missing, 1 = answer given) in sequence (tetrachoric correlation).

Trial Locations

Locations (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council; 🇮🇹 Palermo, Sicily, Italy