AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood

Healthy Clinical Trial

— AQUAPed  

Official title:

AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286894
• Other study ID #: 7/2017_D
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2018
• Source: Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1264
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Italy	Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council	Palermo	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Question difficulty	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).	Study end (4 months)
Secondary	Patterns of missing response	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).	Study end (4 months)
Secondary	Patterns of non-missing responses	Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity).	Study end (4 months)