TRACK: Validation of the Portuguese Version

NCT ID: NCT03290222

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-22

Study Completion Date

2018-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Respiratory Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

TRACK questionnaire

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gustavo Wandalsen

Professor of the Pediatrics Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Allergy and Clinical Immunology

São Paulo, , Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19348922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21906790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24811025 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30534341 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ESR-16-12088

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric ASTHMA-Educator
NCT03520881 COMPLETED NA
Exercise Rehabilitation for Children With Asthma
NCT06272604 NOT_YET_RECRUITING NA
Asthma in Children
NCT01286532 COMPLETED
Childhood Asthma Perception Study
NCT02702687 COMPLETED NA
Asthma Learning Project
NCT00874900 UNKNOWN NA