Trials / Completed
CompletedNCT03273933
DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica · Academic / Other
- Sex
- All
- Age
- 6 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DragONE | 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. |
| DEVICE | SmartOne | A little portable spirometer connected to DragONE allows daily PEF monitoring. |
Timeline
- Start date
- 2018-03-08
- Primary completion
- 2020-02-26
- Completion
- 2020-02-26
- First posted
- 2017-09-06
- Last updated
- 2020-06-09
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT03273933. Inclusion in this directory is not an endorsement.