TRACK: Validation of the Portuguese Version

Completed

• Conditions: Asthma; Respiratory Disease
• Interventions: Other: TRACK questionnaire

• Registration Number: NCT03290222
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2017-08-22
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Primary Completion: 2018-02-01
• Study Completion: 2018-04-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TRACK	TRACK questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Global Initiative for Asthma (GINA) criteria	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
Respiratory symptoms	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 Outcome Measures

Name	Time	Method
Medical opinion	4 weeks	Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion

Trial Locations

Locations (1)

Division of Allergy and Clinical Immunology; 🇧🇷 São Paulo, Brazil