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Completed

NCT Number: NCT03286894

AQUAPed: Validation Study of AQUA© Questionnaire Modified for Childhood

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.

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Key information

Conditions

Healthy

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Question difficulty

    Time frame: 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 outcomes

  1. Patterns of missing response

    Time frame: 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).

  2. Patterns of non-missing responses

    Time frame: Study end (4 months)

    Analysis of the distribution of non-missing responses, possibly stratified by children characteristics (in particular age, sex and physical activity).

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Registry information

Acronym: AQUAPed

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2017
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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