TRACK: Validation of the Portuguese Version

Asthma Clinical Trial

— TRACK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290222
• Other study ID #: ESR-16-12088
• Status: Completed
• Start date: August 22, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: July 2018
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: April 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

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

Locations

Country	Name	City	State
Brazil	Division of Allergy and Clinical Immunology	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	AstraZeneca

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. — View Citation

Rodríguez-Martínez 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Medical opinion	Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion	4 weeks