Towards Digital Management of Paediatric Asthma

Not Applicable

Not yet recruiting

• Conditions: Pediatric Asthma

• Registration Number: NCT06902766
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-28
• Study First Posted: 2025-03-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Study Start: 2025-10
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Asthma control	At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group	Evolution in the overall Childhood Asthma Control Test (c-ACT) score. The c-ACT (Childhood Asthma Control Test) will be used to evaluate the evolution of asthma control.; The c-ACT ranges from 0 to 24, with higher scores meaning better asthma control (better outcome).
Severe exacerbations requiring oral steroids	During the eight-month follow up period in each group	Severe exacerbations (defined as an exacerbation requiring oral corticosteroid therapy): number of severe exacerbations per patient and percentage of patients with at least one severe exacerbation
Severe exacerbations requiring emergency department visit and/or hospital admission.	During the eight-month follow up period in each group	Severe exacerbations requiring emergency department visits and/or hospitali admission: number per patient and percentage of patients with at least one
Children's lung function	At the inclusion visit (baseline) and 8 months (+/- 1 month) (end study) in each group	Evolution of lung function assessed by the predicted percentage of the forced expiratory volume in one second (FEV1) in children aged 7 to 12 years
Quality of life questionnaire	At the inclusion visit (baseline) and 8 months (+/- 1 month) (end of study) in each group	Children (aged 7 -12 years) were assessed by the mini Pediatric Asthma Quality of Life Questionnaire (mPAQLQ). Their parents were assessed by the Pediatric Asthma Caregivers' Quality of Life.
Adherence	During the eight-month follow up period in each group	The adherence of patients to their maintenance treatment, automatically recorded via digital inhalers, defined as the number of doses taken divided by the number of doses prescribed x 100: average percentage of adherence
Reliever treatment	During the eight-month follow up period in each group	Use of reliever treatment (salbutamol) is automatically recorded via digital inhalers: average number of uses per each patient
Number of teleconsultations/consultations	During the eight-month follow up period in each group	Average number of consultations/teleconsultations per patient, scheduled and unscheduled, and their average cumulative duration per patient
Children participation	During the eight-month follow up period in each group	The child's speaking time compared to the total speaking time (child + parent + doctor), expressed as a percentage was determined from video recordings.; The number of the child's speech turns compared to the total number of speech turns (child + parent + doctor), expressed as a percentage.; The number of complete thoughts, or "utterances", of the child compared to the total number of complete thoughts, expressed as a percentage.; The child's non-verbal communication, analyzed by a module of the Roter Interactive Assessment System
Absenteeism	During the eight-month follow up period in each group	Number of days of asthma-related absenteeism (from school for children and work for parents), per patient
Satisfaction of parents	After 8 months (+/- 1 month) (end of study)	Assessed by the proportion of parents in the experimental group responding on a custom questionnaire that they wish to continue the digital management experience and the reason for their choice
Satisfaction of doctors	After 8 months (+/- 1 month) (end of study)	Assessed by the proportion of doctors in the experimental group responding on a custom questionnaire that they wish to continue the digital management experience and the reason for their choice

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades AP-HP; 🇫🇷 Paris, France