TRACK: Validation of the Portuguese Version

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Asthma, Respiratory Disease

Intervention / Treatment
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* Other: TRACK questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TRACK<br>Children will be followed for four weeks (3 to 5 weeks) after the inclusion in the study. Parents will complete the TRACK questionnaire in both visit and will answer additional questions about respiratory symptoms and use of medication. | Other: TRACK questionnaire<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical opinion | Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory symptoms, Children