TRACK: Validation of the Portuguese Version

Federal University of São Paulo

Status: Completed

Conditions: Asthma; Respiratory Disease

Treatments: Other: TRACK questionnaire

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03290222

ESR-16-12088

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

299 participants in 1 patient group

TRACK

Description:

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.

Treatment:

Other: TRACK questionnaire