DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Acquisition and maintenance of the control status
研究概览
简要总结
Randomized clinical trial to assess acquisition and maintenance of paediatric asthma control through innovative devices supporting usual care. In the first study arm, a new application (DragONE) for iOS and Android will be only used for patient monitoring. In the second study arm, a small portable device (SmartONE) will also be connected to the DragONE APP, for daily assessment of the peak expiratory flow (PEF). The study duration is 12 weeks. The main outcome of the study is the Childhood Asthma Control Test (C-ACT) score, assessed once every 4 weeks for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of moderate persistent asthma
- •Uncontrolled symptoms (C-ACT≤ 19)
- •Treated for at least 3 months
- •FEV1 between 60% and 90% of predicted value
排除标准
- •Symptoms of acute respiratory infection
- •Immunological or metabolic systemic disease
- •Major malformations of the upper airways
- •Active smoker
研究组 & 干预措施
10 children with DragONE only
干预措施: DragONE (Device)
10 children with DragONE and SmartOne
干预措施: DragONE (Device)
10 children with DragONE and SmartOne
干预措施: SmartOne (Device)
结局指标
主要结局
Acquisition and maintenance of the control status
时间窗: Once every 4 weeks, for 12 weeks
mean C-ACT score
次要结局
- Quality of life in asthma children(12 weeks)
- Adherence to asthma treatment(12 weeks)
- Lung function: FVC(12 weeks)
- Lung function: FEV1(12 weeks)
- Lung function: FEF 25-75(12 weeks)
研究者
Stefania La Grutta, MD
Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Istituto per la Ricerca e l'Innovazione Biomedica