Asthma
Conditions
Interventions
This is a randomized, controlled, two-arm clinical trial with blinded outcome assessment. A total of 120 participants will be included and randomly allocated into two groups of 60 individuals each: In
(2) inspiratory time between 6 and 10 seconds and a 30-second breath-hold, according to technical recommendations
and (3) correct assembly of the device, including proper fitting, inhaler positioning, and use of a mask when applicable. Feedback will be delivered in
Sponsors
Universidade Municipal de São Caetano do Sul
Universidade Municipal de São Caetano do Sul
Eligibility
Age
4 Years to 14 Years
Inclusion criteria
Inclusion criteria: Children aged between 4 and 14 years. Of both sexes. With a diagnosis of Asthma and a prescription for inhalation therapy with pressurized metered-dose inhalers (MDI) with spacers. Authorization and Informed Consent Form signed by the legal guardian. Access to the OxyKids application (smartphone or tablet)
Exclusion criteria
Exclusion criteria: Patients exclusively using conventional nebulizers or dry powder inhalers (DPI). Children with severe respiratory comorbidities (for example: cystic fibrosis, bronchopulmonary dysplasia). Unavailability of digital access or refusal to use the application. Absence of legal guardian consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the OxyKids software intervention in correcting the pressurized inhaler technique, measured by expert video analysis, based on a checklist of critical steps. It is expected that the intervention will result in a significant increase in the percentage of correct critical steps of the inhalation technique in the intervention group compared to the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the impact of the intervention on pediatric subjective perception of fatigue, therapeutic adherence, and clinical control of asthma, measured, respectively, through the Pediatric Subjective Perception of Fatigue Scale, the number of inhalation records on the platform, and the Asthma Control Test, in addition to the global perception of the intervention assessed by the Global Perceived Effectiveness (GPE) scale. It is expected that, compared to the control group, the intervention group will show: a) a reduction in pediatric subjective fatigue perception; b) an increase in therapeutic adherence, verified by the number of records on the platform; c) improvement in clinical asthma control, measured by the Asthma Control Test; and d) a positive global perception of the intervention, assessed by the Global Perceived Effectiveness (GPE) scale. | — |
Countries
Brazil
Contacts
Public ContactClaudia Alvarenga
GetInOxy – Healthtech
Outcome results
None listed