Towards Digital Management of Paediatric Asthma

Condition(s) studied

Investigational drug(s) / intervention(s)

Active telemonitoring using real-time data from digital inhalers.: Telemonitoring system relying on the use of 2 digital inhalers FindAir ONE for pMDI,one for the controller the other for the reliever treatment. Active telemonitoring using real-time data from digital inhalers Investigators will be alerted by email if a child: * fails to take his or her controller treatment for 4 continuous days and/or * uses \> 4 doses of reliever treatment over 24 hours * uses \< 12 doses of reliever treatment over 3 months (indication to decrease the controller treatment). For alert (2), a teleconsultation will be scheduled within 2 working days to assess and adapt treatment as needed. Emergency treatment may be adjusted for approximately one week. Alerts within the following 7 days will be considered part of the same clinical episode. For alerts (1) and (3), a teleconsultation will be scheduled within 7 working days to assess and adapt management as needed.Spirometry and pulse oximetry if needed.

Standard: Standardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in asthma severity measured by the Composite Asthma Severity Index (CASI) — At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group
  The CASI is a validated composite score that evaluates asthma severity by incorporating measures of asthma symptoms, exacerbations, lung function, and treatment level. The change in CASI score will be compared between groups, calculated as the difference between the final score (at 8 months) and the baseline score. Lower scores indicate less severe asthma. The CASI ranges from 0 to 17, with higher scores meaning a higher severity (worse outcome).

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France