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TRACK: Validation of the Portuguese Version (TRACK)

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ClinicalTrials.gov Identifier: NCT03290222
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Gustavo Wandalsen, 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.

Condition or disease Intervention/treatment
Asthma Respiratory Disease 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
Estimated Enrollment : 220 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Translation, Adaptation Into Portuguese (Brazilian Culture) and Validation of the Test for Respiratory and Asthma Control in Kids (TRACK)
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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




Primary Outcome Measures :
  1. Global Initiative for Asthma (GINA) criteria [ Time Frame: 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

  2. Respiratory symptoms [ Time Frame: 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 :
  1. Medical opinion [ Time Frame: 4 weeks ]
    Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290222


Contacts
Contact: Gustavo F Wandalsen, MD 5511993061944 gfwandalsen@uol.com.br
Contact: Renata Dias, MD 551155764848 ext 3068 renatadias.fmj@gmail.com

Locations
Brazil
Division of Allergy and Clinical Immunology Recruiting
São Paulo, Brazil, 0425002
Contact: Gustavo F Wandalsen, MD    5511993061944    gfwandalsen@uol.com.br   
Sponsors and Collaborators
Federal University of São Paulo
AstraZeneca

Publications:
Responsible Party: Gustavo Wandalsen, Professor of the Pediatrics Department, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT03290222     History of Changes
Other Study ID Numbers: ESR-16-12088
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gustavo Wandalsen, Federal University of São Paulo:
Respiratory symptoms
Children

Additional relevant MeSH terms:
Asthma
Respiration Disorders
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases