Towards Digital Management of Paediatric Asthma (FrenchCare)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Pediatric Asthma

Treatments: Other: Standard; Device: Active telemonitoring using real-time data from digital inhalers.

Study type: Interventional

Funder types: Other

Identifiers

NCT06902766

APHP211434

ID-RCB Number:2022-A02649-34 (Other Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Digital medicine

Experimental group

Description:

Active telemonitoring using real-time data from digital inhalers

Treatment:

Device: Active telemonitoring using real-time data from digital inhalers.

Standardized medicine

Active Comparator group

Description:

The patients are monitored as usual according to the standard care protocol. Patients will receive 2 digital inhalers, but only to record their treatment use.

Treatment:

Other: Standard