Towards Digital Management of Paediatric Asthma

Official title

Towards Digital Management of Pediatric Asthma:a Pilot Study

Overview

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.

Interventions

• Device 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: 1. fails to take his or her controller treatment for 4 continuous days and/or 2. uses \> 4 doses of reliever treatment over 24 hours 3. uses \< 12 doses of reliever treatment over 3 months (indication to decrease the controller treatm
• Other Standard
  Standardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers

Primary outcome measures

• Change in asthma severity measured by the Composite Asthma Severity Index (CASI) [Time frame: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group]

Secondary outcome measures (12)

• Asthma control [Time frame: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group]
• Severe exacerbations requiring oral steroids [Time frame: During the eight-month follow up period in each group]
• Severe exacerbations requiring emergency department visit and/or hospital admission. [Time frame: During the eight-month follow up period in each group]
• Children's lung function [Time frame: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end study) in each group]
• Quality of life questionnaire [Time frame: At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group]
• Adherence [Time frame: During the eight-month follow up period in each group]
• Reliever treatment [Time frame: During the eight-month follow up period in each group]
• Number of teleconsultations/consultations [Time frame: During the eight-month follow up period in each group]
• Children participation [Time frame: During the eight-month follow up period in each group]
• Absenteeism [Time frame: During the eight-month follow up period in each group]
• Satisfaction of parents [Time frame: After 8 months (+/- 1 month) (end of study)]
• Satisfaction of doctors [Time frame: After 8 months (+/- 1 month) (end of study)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Hôpital Necker Enfants Malades AP-HP — Paris

Identifiers

NCT: NCT06902766 · APHP211434 · ID-RCB Number:2022-A02649-34

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗