TRACK: Validation of the Portuguese Version (TRACK)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03290222|
Recruitment Status : Completed
First Posted : September 21, 2017
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment|
|Asthma Respiratory Disease||Other: TRACK questionnaire|
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|
|Actual Enrollment :||299 participants|
|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|
|Actual Primary Completion Date :||February 1, 2018|
|Actual Study Completion Date :||April 1, 2018|
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
- 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
- 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)
- 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
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
|Division of Allergy and Clinical Immunology|
|São Paulo, Brazil, 0425002|