DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices

Study Overview
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Brief Summary
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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.

Official Title
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DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices

Conditions
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Asthma

Intervention / Treatment
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* Device: DragONE
* Device: SmartOne


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of moderate persistent asthma Uncontrolled symptoms (C-ACT≤ 19) Treated for at least 3 months FEV1 between 60% and 90% of predicted value Exclusion Criteria: Symptoms of acute respiratory infection Immunological or metabolic systemic disease Major malformations of the upper airways Active smoker

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 children with DragONE only<br> | Device: DragONE<br>* 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.<br>|
| Experimental: 10 children with DragONE and SmartOne<br> | Device: DragONE<br>* 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.<br>Device: SmartOne<br>* A little portable spirometer connected to DragONE allows daily PEF monitoring.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acquisition and maintenance of the control status | mean C-ACT score | Once every 4 weeks, for 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life in asthma children | PAQLQ score | 12 weeks | 
| Adherence to asthma treatment | MARS score | 12 weeks | 
| Lung function: FEV1 | Forced expiratory volume in the first second | 12 weeks | 
| Lung function: FVC | Forced vital capacity | 12 weeks | 
| Lung function: FEF 25-75 | Forced expiratory flow at 25-75% | 12 weeks |