Towards Digital Management of Paediatric Asthma
Recruiting · NCT06902766 · Interventional (participants receive a specific treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This pilot study aims to explore whether a digital approach to managing childhood asthma using connected inhalers and video consultations triggered by alerts from these devices - could work as well as standard in-person care. The connected inhalers track when children use their daily prevention medication and their rescue medication for asthma symptoms. If a child misses several days of prevention medication or uses their rescue inhaler frequently, their doctor receives an alert and can schedule a video consultation to adjust their treatment. Fifty children aged 4-12 years with asthma will participate for 8 months, with half using this digital system and half receiving usual care. The study will measure whether this new approach is practical and acceptable to families and doctors, and will look at its effects on asthma control, quality of life, and healthcare use. The results will help design a larger study to fully test if this digital approach could improve asthma care for children.
Who can take part
Inclusion criteria
- Aged 4 to 12, whose asthma has been diagnosed by a physician
- Followed up for their asthma by a pediatrician or pediatric pulmonologist
- With asthma severity corresponding to GINA grades 2, 3 or 4 (Global Asthma Initiative Guidelines)
- Whose controller and reliever treatments are administered using pressurized metered-dose inhalers (p-MDIs)
- With social security
- Whose parents or legal guardian(s):
- Have given their written and informed consent for their child's participation and their participation,
- Have a smartphone in the household that can download the application and is compatible with it,
- Are capable, in the opinion of the investigator, of understanding the use of the mobile application and module FRENCH CARE specifically dedicated to the research and the digital inhalers provided.
- Non-inclusion Criteria:
- Patients with another pathology that could interfere with the evaluation of the endpoints (e.g, bronchopulmonary dysplasia, cystic fibrosis, etc.)
- Patients whose parents or legal representative(s) are, in the opinion of the investigator, unable to understand the purpose of the study and/or express their consent.
- Patients benefiting from State Medical Aid
Exclusion criteria
- \- Patient who did not use the system within 15 days of the inclusion visit
Where it is running
1 location listed.
- Hôpital Necker Enfants Malades AP-HP - Paris, France