Clinical trial NCT04810169: Towards Participatory Paediatric Asthma Action Plans
Official title: Towards Participatory Paediatric Asthma Action Plans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Action plan
Asthma
Paediatric
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with asthma

Brief summary: Asthma is the most common chronic disease in children. The management of asthma attacks at home is based on asthma action plans that are very heterogeneous and reflect the diversity of recommendations on this subject. The purpose of this study is to observe using smartinhalers how children and their families use their emergency treatment at home in case of asthma symptoms and asthma attacks, to allow building new recommendations based not only on the literature, but also on real-world data.

Detailed description: Asthma is the most common chronic disease in children. Asthma exacerbations are responsible for many unscheduled consultations by paediatricians and general practitioners, numerous emergency room visits and frequent hospitalizations

Asthma action plans are documents given to families and schools to give the actions to be taken in the event of an asthma attack occurring in the family or school environment. They are recommended by all learned societies, because, combined with patient education and regular consultations, they reduce the need for unscheduled care.

The main drug in the action plan is the emergency treatment, i.e. a short-acting bronchodilator (SABA). However, the doses of SABA to be used vary widely depending on the recommendations. For children up to 5 years of age, the international board of the Global Initiative for Asthma (GINA) suggests limiting the home dose to 2 puffs of 100μg every 20 minutes, to be repeated twice before consulting a physician if there is no improvement. This dose is increased to 4-10 puffs every 20 minutes in children 6 years and older. The British Thoracic Society in the United Kingdom advises administering salbutamol puffs one at a time, 30 to 60 seconds apart, until symptoms improve, with a maximum of 10 puffs. In France, the Groupe de Recherche sur les Avancées en PneumoPédiatrie (GRAPP) recommends to administer higher doses of salbutamol at home, up to one puff per 2 kg of weight, with a maximum of 10 to 15 puffs, to be repeated every 20 minutes for one hour, before giving oral corticosteroids. These very heterogeneous protocols reflect the diversity of doses proposed in the literature, and the paucity of clinical research data that makes it impossible to determine whether one approach is better than another. A study that looked at the goals of parents of children with asthma highlighted that this heterogeneity of practices is a source of stress for families: "I would like one plan and not ten" explained one parent; "I would like a plan that doesn't change all the time" reported another.

Harmonization of practices is necessary in order to provide families and school physicians nurses with a consistent approach..

The aim of this study is therefore to observe, using inhalers connected to salbutamol inhalers (smart inhalers), how families manage an asthma exacerbation at home, and to integrate these data into the establishment of future recommendations.

Eligibility criteria: Inclusion Criteria:

* Parent of 18 years or more
* Parent with a smartphone compatible with a smart inhaler
* Parent with child who :

  * is 3 years to 11 years 11 months old
  * has physician-diagnosed asthma diagnosis
  * has a prescription of emergency treatment in case of asthma symptom
* Non-opposition of the legal guardian

Exclusion Criteria:

* Refuse to participate at the study
* Difficulty reading and/or understanding French language
* Technical problem (malfunction) with the smart inhalers and/or the associated mobile application during the initial test with the parent's smartphone

Primary outcomes:
measure: Mean number of emergency-treatments administered in the first two hours of management
timeFrame: 6 months
Secondary outcomes:
measure: Improvement of one or more symptoms
timeFrame: 6 months
measure: Elimination of one or more symptoms
timeFrame: 6 months
measure: Compliance score for action plan
timeFrame: 6 months
measure: Overtreatment by families
timeFrame: 6 months
measure: Undertreatment by families
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: David DRUMMOND, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marguet C, Michelet I, Couderc L, Lubrano M. [Management of acute asthma exacerbation in childhood: French recommendations]. Arch Pediatr. 2009 Jun;16(6):505-7. doi: 10.1016/S0929-693X(09)74046-1. No abstract available. French.
citation: Pinnock H, Parke HL, Panagioti M, Daines L, Pearce G, Epiphaniou E, Bower P, Sheikh A, Griffiths CJ, Taylor SJ; PRISMS and RECURSIVE groups. Systematic meta-review of supported self-management for asthma: a healthcare perspective. BMC Med. 2017 Mar 17;15(1):64. doi: 10.1186/s12916-017-0823-7.
citation: Heidi M, Emily K, Benjamin H, Michael C, Robert K, Mitch B, Chris G, Mando W, Andrew B. Patient reported outcomes for preschool children with recurrent wheeze. NPJ Prim Care Respir Med. 2019 Mar 26;29(1):7. doi: 10.1038/s41533-019-0120-3.