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Completed

NCT Number: NCT03290222

TRACK: Validation of the Portuguese Version

The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is a validated instrument to evaluate the control of respiratory symptoms in young children. The TRACK questionnaire was developed in English and a version in Portuguese is not available or validated, purpose of the present project.

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Key information

About this study

The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is the only instrument developed and validated so far to evaluate the control of respiratory symptoms in young children under five years of age. The TRACK questionnaire consists of five questions, scored from 0 to 20, given to caregivers of children with asthma or recurrent respiratory symptoms, and addresses respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilator medications over the past three months and systemic corticosteroids in the last year.

The TRACK questionnaire was developed in English and has already been translated and validated into Spanish and Arabic. At the moment there is no translation and validation of the TRACK questionnaire for the Portuguese language, purpose of the present project.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Native Portuguese speakers families
  • Medical diagnosis of asthma or history of at least three episodes of cough and/or wheeze and/or dyspnea (duration longer than 24 hours) and treated with bronchodilators

Exclusion criteria

  • Other relevant pulmonary diseases (i.e.: cystic fibrosis, bronchopulmonary dysplasia)
  • Systemic diseases (i.e.: heart diseases, neurologic disorders)
  • Premature birth (under 37 weeks of gestational age)
  • Congenital malformations
  • Illiteracy and/or inability of parents to understand the questionnaire

Treatment and study plan

TRACK questionnaire

Other

TRACK questionnaire consists of five questions, scored 0-20, to be made to caregivers of children with asthma or recurrent respiratory symptoms, regarding respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilators in the last three months and systemic corticosteroids in the last year

Primary outcomes

  1. Global Initiative for Asthma (GINA) criteria

    Time frame: 4 weeks

    The TRACK criterion validation will be performed by the comparison of the scores obtained from patients in the three levels of control, according to GINA criteria

  2. Respiratory symptoms

    Time frame: 4 weeks

    Constructive validation will be done by comparing the TRACK notes between patients discriminated according to their respiratory symptoms (symptomatic, recent symptoms, and asymptomatic)

Secondary outcomes

  1. Medical opinion

    Time frame: 4 weeks

    Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

Translation, Adaptation Into Portuguese (Brazilian Culture) and Validation of the Test for Respiratory and Asthma Control in Kids (TRACK)

Acronym: TRACK

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 21, 2017
Registry last updated
Aug 1, 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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