Translation, Adaptation Into Portuguese (Brazilian Culture) and Validation of the Test for Respiratory and Asthma Control in Kids (TRACK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Global Initiative for Asthma (GINA) criteria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Global Initiative for Asthma (GINA) criteria
时间窗: 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
时间窗: 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)
次要结局
- Medical opinion(4 weeks)
研究者
Gustavo Wandalsen
Professor of the Pediatrics Department
Federal University of São Paulo