Assessment of Children and Adolescents With Asthma: An Observational Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 525
- 试验地点
- 15
- 主要终点
- Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ)
研究概览
简要总结
The purpose of this study is to assess the evolution of disease control, health-related quality of life, and the risk of severe asthma exacerbations in children and adolescents with persistent asthma in Spain at short, mid and long-term follow-up. Patient-reported information in this project is collected by computer assisted telephone interviews (CATI) and a mobile application (ARCA App).
详细描述
Primary Objectives:
- To evaluate the asthma control in children and adolescents with persistent asthma, and its relationship with patient characteristics, treatment and health-related variables (treatment adherence, inhalation technique, inhaler device, asthma triggers, and smoking exposure, among others).
- To assess the health-related quality of life of children and adolescents with persistent asthma, and its relationship with patient characteristics, treatment and health-related variables (asthma control, treatment adherence and inhalation technique, inhaler device, asthma triggers, and smoking exposure, among others).
- To assess the risk of severe asthma exacerbations in children and adolescents with persistent asthma and its relationship with patient characteristics, treatment, and health-related variables (asthma control, treatment adherence and inhalation technique, inhaler device, health-related quality of life, asthma triggers, and smoking exposure, among others).
Secondary Objectives:
- To evaluate the effect of monitoring inhalation techniques on patients' performance according to recommended actions when using inhalers, and outcomes such as asthma control, health-related quality of life, and asthma exacerbations.
- To assess the treatment adherence in children and adolescents with persistent asthma, and its relationship with other treatment-related factors (inhaler technique, inhaler device, adherence attitudes, and beliefs about illness, inhaler and exacerbations, among others).
- To evaluate health inequalities in children and adolescents with asthma in Spain.
ARCA is a prospective multicenter observational study in children and adolescents with a clinical diagnosis of persistent asthma. This clinical diagnosis of asthma is defined as the presence of wheezing three times in the last year that improves with the use of bronchodilators. Participants are consecutively recruited in outpatient pediatric pulmonology hospital consultations and primary care physicians.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children or adolescents aged 6-
- •Clinical diagnosis of asthma.
- •Undergoing treatment with inhaled corticosteroids (alone or combined with long-acting beta-agonists) for more than 6 months in the previous year.
- •With access to a smart phone (their own, or their parents').
排除标准
- •Concomitant respiratory diseases:
- •Chronic obstructive pulmonary disease
- •Cystic fibrosis
- •Pulmonary fibrosis
- •Bronchiectasis
- •Active tuberculosis,
- •Immunodeficiency associated with alpha 1 antitrypsin deficiency
- •Ciliary diseases
研究组 & 干预措施
Asthma Research in Children and Adolescents - Spanish Cohort
Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring
干预措施: Inhaled Corticosteroids (ICs) (Drug)
Asthma Research in Children and Adolescents - Spanish Cohort
Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring
干预措施: Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA) (Drug)
Asthma Research in Children and Adolescents - Spanish Cohort
Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring
干预措施: Other treatments (Drug)
Asthma Research in Children and Adolescents - Spanish Cohort
Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring
干预措施: Inhaler device (Drug)
Asthma Research in Children and Adolescents - Spanish Cohort
Groups defined according to treatments prescribed during regular clinical practice and to the exposure to inhalation techniques monitoring
干预措施: Regularly monitoring of the Inhalation technique through mobile app (Behavioral)
结局指标
主要结局
Change from baseline in symptoms control, measured with the Asthma Control Questionnaire (ACQ)
时间窗: 2, 5, 7 and 10 years after inclusion
Symptoms control is measured with the Asthma Control Questionnaire (ACQ-symptoms) only, which assesses the frequency of 5 asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheeze) during the previous week on a 7-point Likert scale from 0 (no impairment) to 6 (maximum impairment). The overall score, calculated as the mean of item responses, ranges from 0 to 6. A score \>1.5 is considered not well-controlled asthma, and scores \<0.75 well-controlled asthma.
Change from baseline in Health-Related Quality of Life, measured with the EuroQol
时间窗: 2, 5, 7 and 10 years after downloading the ARCA app
The EQ-5D consists of 5 dimensions ("mobility", "looking after myself", "doing usual activities", "having pain/discomfort" and "feeling worried/sad/unhappy). It includes also a visual analogue scale (EQ-VAS) on the general health status from 0 (worst health status) to 100 (best health status possible). The EQ-5D index ranges from 1 (best health state) to negative values (health states valued as worse than death), where 0 is equal to death, allowing the calculation of Quality-Adjusted Life-Years (QALYs).
Number of severe asthmatic exacerbations
时间窗: 5 and 10 years after inclusion
As a screening to detect asthma exacerbation, the experience of asthma worsening question is administered through the ARCA app: "In the last month, have you had to take any pill, syrup, oral solution or go to the doctor or hospital, due to asthma worsening?" (Yes/No). If the answer is "yes", a phone call confirms or discards a severe asthma exacerbation through the following questions: "Did you visit or phone your general practitioner, out-of-hours, or walk-in center because your asthma got worse?", "Did you call an ambulance or go to the hospital because of your asthma?", "Did you take steroids tablets (such as Prednisolone or Deltacortril) for at least 2 days because of your asthma?" If the participant answers "yes" to at least one of the 3 questions, an asthma exacerbation is confirmed. These questions were constructed applying the definition of the American Thoracic Society and the European Respiratory Society.
次要结局
- Change from baseline in the Pediatric Asthma Impact Scale (PAIS)(2, 5, 7 and 10 years after downloading the ARCA app)
- Change from baseline in adherence to the treatment, measured with the Medication Intake Survey adherence scale-Asthma (MIS-A)(2, 5, 7 and 10 years after inclusion)
- Change from baseline in quality of the inhaler technique, measured with the Inhalation Technique Scale(2, 5, 7 and 10 years after downloading the ARCA app)