TRACK: Validation of the Portuguese Version

NCT03290222 | Completed DMC

• 1 other identifier: ESR-16-12088
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Respiratory Disease

Keywords

Respiratory symptoms; Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Medical opinion

  4 weeks

Study Arms (1)

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

Interventions

TRACK questionnaire OTHER

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

TRACK

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• AstraZeneca: collaborator

Study Sites (1)

Division of Allergy and Clinical Immunology

São Paulo, 0425002, Brazil

Location

Related Publications (4)

• 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.

  PMID: 19348922 BACKGROUND

• 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.

  PMID: 21906790 BACKGROUND

• 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.

  PMID: 24811025 BACKGROUND

• 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.

  PMID: 30534341 DERIVED

MeSH Terms

Conditions

Asthma; Respiration Disorders; Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Pediatrics Department

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: August 22, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

BR (1)