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TRACK: Validation of the Portuguese Version

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03290222
Acronym
TRACK
Enrollment
299
Registered
2017-09-21
Start date
2017-08-22
Completion date
2018-04-01
Last updated
2018-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Respiratory Disease

Keywords

Respiratory symptoms, Children

Brief summary

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

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.

Interventions

OTHERTRACK questionnaire

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

Sponsors

AstraZeneca
CollaboratorINDUSTRY
Federal University of São Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Global Initiative for Asthma (GINA) criteria4 weeksThe 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
Respiratory symptoms4 weeksConstructive validation will be done by comparing the TRACK notes between patients discriminated according to their respiratory symptoms (symptomatic, recent symptoms, and asymptomatic)

Secondary

MeasureTime frameDescription
Medical opinion4 weeksConstructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026