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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
28
The DragONE application for iOS and Android, developed in collaboration with the Institute for Educational Technologies of the National Research Council of Palermo, allow children to daily fill electronically the C-ACT questionnaire and the symptom diary card.
A little portable spirometer connected to DragONE allows daily PEF monitoring.
Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo
Palermo, Italy
Acquisition and maintenance of the control status
mean C-ACT score
Time frame: Once every 4 weeks, for 12 weeks
Quality of life in asthma children
PAQLQ score
Time frame: 12 weeks
Adherence to asthma treatment
MARS score
Time frame: 12 weeks
Lung function: FEV1
Forced expiratory volume in the first second
Time frame: 12 weeks
Lung function: FVC
Forced vital capacity
Time frame: 12 weeks
Lung function: FEF 25-75
Forced expiratory flow at 25-75%
Time frame: 12 weeks
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