TRACK: Validation of the Portuguese Version (TRACK)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Respiratory Disease
• Intervention / Treatment: Other: TRACK questionnaire

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 Type: Observational
• Enrollment (Actual): 299

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 0425002
    • Division of Allergy and Clinical Immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children up to five years of age with recurrent respiratory symptoms attended at pediatric clinics will be included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TRACK; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: AstraZeneca

Publications and helpful links

General Publications

• Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.
• Zeiger RS, Mellon M, Chipps B, Murphy KR, Schatz M, Kosinski M, Lampl K, Ramachandran S. Test for Respiratory and Asthma Control in Kids (TRACK): clinically meaningful changes in score. J Allergy Clin Immunol. 2011 Nov;128(5):983-8. doi: 10.1016/j.jaci.2011.08.010. Epub 2011 Sep 8. Erratum In: J Allergy Clin Immunol. 2012 Jan;129(1):270.
• Rodriguez-Martinez CE, Nino G, Castro-Rodriguez JA. Validation of the Spanish version of the Test for Respiratory and Asthma Control in Kids (TRACK) in a population of Hispanic preschoolers. J Allergy Clin Immunol Pract. 2014 May-Jun;2(3):326-31.e3. doi: 10.1016/j.jaip.2014.01.014. Epub 2014 Mar 29.
• Wandalsen GF, Dias RG, Chong-Neto HJ, Rosario N, Moraes L, Wandalsen NF, Medeiros D, Bianca ACD, Urrutia-Pereira M, Avila J, Jorge PP, Sole D. Test for Respiratory and Asthma Control in Kids (TRACK): validation of the Portuguese version. World Allergy Organ J. 2018 Dec 5;11(1):40. doi: 10.1186/s40413-018-0219-y. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (Actual): September 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Children; Respiratory symptoms
• Additional Relevant MeSH Terms: Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: ESR-16-12088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No