NCT Number: NCT06902766
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.
Interested in participating?
Request Info4 year–12 year
All sexes
Interventional
Not applicable
Paris, 75015, France
Location status: Recruiting
David DUMMOND, MD, PhD
CONTACT
01 87 89 20 28 ext. +33
David DUMMOND, MD,PhD
PRINCIPAL_INVESTIGATOR
Sarah BOUCHARD, Project advisor
CONTACT
01 42 19 28 79 ext. +33
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non-inclusion Criteria:
Exclusion criteria
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:
In these cases, investigators will be asked to schedule a teleconsultation within 2 working days with the family and to adapt treatments as needed. They may ask the family to use the portable spirometer and oximeter if necessary.
No systematic consultation will be planned.
Standardized care + passive recording of asthma treatment use (controller and reliever treatments) using digital inhalers
Time frame: 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).
Time frame: 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 min to 27 max, with higher scores meaning better asthma control (better outcome).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
David DUMMOND, MD, PhD
CONTACT
01 87 89 20 28 ext. +33
sarah BOUCHARD, Project manager
CONTACT
01 42 19 28 79 ext. +33
Assistance Publique - Hôpitaux de Paris
Other
Towards Digital Management of Pediatric Asthma:a Pilot Study
Acronym: FrenchCare
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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