TRACK: Validation of the Portuguese Version

Federal University of São Paulo299 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

299

Conditions

Asthma Respiratory Disease

Interventions

TRACK questionnaireOTHER

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

Eligibility

Sex: ALLMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Allergy and Clinical Immunology

São Paulo, Brazil

Outcomes

Primary Outcomes

Global Initiative for Asthma (GINA) criteria

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

Time frame: 4 weeks

Respiratory symptoms

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

Time frame: 4 weeks

Secondary Outcomes

Medical opinion

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

Time frame: 4 weeks

Data from ClinicalTrials.gov

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