DragONE Study: Acquisition and Maintenance of Paediatric Asthma Control: Usual Care vs Innovative Devices
DragONE
1 other identifier
interventional
28
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable asthma
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedStudy Start
First participant enrolled
March 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2020
CompletedJune 9, 2020
June 1, 2020
2 years
September 5, 2017
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Acquisition and maintenance of the control status
mean C-ACT score
Once every 4 weeks, for 12 weeks
Secondary Outcomes (5)
Quality of life in asthma children
12 weeks
Adherence to asthma treatment
12 weeks
Lung function: FEV1
12 weeks
Lung function: FVC
12 weeks
Lung function: FEF 25-75
12 weeks
Study Arms (2)
10 children with DragONE only
ACTIVE COMPARATOR10 children with DragONE and SmartOne
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of moderate persistent asthma
- Uncontrolled symptoms (C-ACT≤ 19)
- Treated for at least 3 months
- FEV1 between 60% and 90% of predicted value
You may not qualify if:
- Symptoms of acute respiratory infection
- Immunological or metabolic systemic disease
- Major malformations of the upper airways
- Active smoker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Biomedicine and Molecular Immunology (IBIM) - National Research Council of Palermo
Palermo, 90146, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.
Study Record Dates
First Submitted
September 5, 2017
First Posted
September 6, 2017
Study Start
March 8, 2018
Primary Completion
February 26, 2020
Study Completion
February 26, 2020
Last Updated
June 9, 2020
Record last verified: 2020-06