Clinical trial NCT06902766: Towards Digital Management of Paediatric Asthma
Official title: Towards Digital Management of Pediatric Asthma:a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Asthma
Keywords: Pediatric asthma
Digital revolution
Digital inhaler
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Asthma is the most common chronic illness in children. In France, two-thirds of children have uncontrolled asthma, meaning they experience symptoms and occasional asthma attacks.

The digital revolution has enabled the development of connected devices, particularly smart inhalers, which collect objective information for assessing asthma from patients' homes. The Covid-19 pandemic has further accelerated the adoption of telemedicine. These new approaches represent a significant shift in paediatric asthma management, offering opportunities for more effective treatment methods.

As a precursor to a larger investigation, this pilot study hypothesises that digital asthma management using proactive remote care through telemedicine consultations triggered by connected device alerts may improve childhood asthma control compared to current management approaches.

Eligibility criteria: 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

Primary outcomes:
measure: Change in asthma severity measured by the Composite Asthma Severity Index (CASI)
timeFrame: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group
Secondary outcomes:
measure: Asthma control
timeFrame: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group
measure: Severe exacerbations requiring oral steroids
timeFrame: During the eight-month follow up period in each group
measure: Severe exacerbations requiring emergency department visit and/or hospital admission.
timeFrame: During the eight-month follow up period in each group
measure: Children's lung function
timeFrame: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end study) in each group
measure: Quality of life questionnaire
timeFrame: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group
measure: Adherence
timeFrame: During the eight-month follow up period in each group
measure: Reliever treatment
timeFrame: During the eight-month follow up period in each group
measure: Number of teleconsultations/consultations
timeFrame: During the eight-month follow up period in each group
measure: Children participation
timeFrame: During the eight-month follow up period in each group
measure: Absenteeism
timeFrame: During the eight-month follow up period in each group
measure: Satisfaction of parents
timeFrame: After 8 months (+/- 1 month) (end of study)
measure: Satisfaction of doctors
timeFrame: After 8 months (+/- 1 month) (end of study)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades AP-HP
Study officials:
affiliation: Hôpital Necker Enfants Malades AP-HP
name: David DUMMOND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: