An interventional study of Happyair Ecosystem in Asthma in Children, sponsored by Lovexair Foundation. Completed at 4 sites in Spain. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Lovexair Foundation · Not applicable, Interventional, and Supportive care
Asthma is the most common chronic respiratory disease worldwide. Despite advances in asthma management, control of the disease is still a challenge especially among children. Information and communications technology (ICT) have been recently used in clinical practice to increase awareness of diseases, encourage patients to engage in the management of their conditions and improve monitoring and surveillance. The investigators of this study will test a new digital platform combining online/offline content aimed to improve asthma control and reduce exacerbations and unnecessary consultations in children with difficult-to-control asthma. A randomised controlled trial enrolling 60 patients allocated in two groups has been designed. The intervention group (IG) will be granted free access during 6 months to a web-based platform. During this period, patient will have access to online/off line content to improve disease awareness, monitor signs and symptoms and will also get the support of a respiratory coach. In addition, patients in this group will receive an electronic peak flow meter to register daily variations in maximal expiratory flow and an electronic device to connect to their inhaler to track adequate intake of inhaled medication. The control group (CG) will receive usual care consisted of scheduled visitations to medical doctors every 4 - 8 weeks. Both groups will be evaluated at baseline, post-intervention (6 months) and at follow up (one year) in the following variables: age, gender, asthma severity classification according to international guidelines, date of diagnosis, weight, height, Body Mass Index (BMI), forced expiratory volume in 1 second (FEV1), Asthma Control Test (ACT) score, treatment received for asthma, number of exacerbations in the previous 6 months and concomitant diseases. Exacerbations will be defined as any worsening in asthma symptoms that requires an increase in the usual therapy, an unscheduled physician visit, treatment in the emergency room or hospitalization.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 60 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →This is the only study on the registry with Lovexair Foundation as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the IG will be given free access to the HappyAir platform during a 6-month period. This platform combines online/offline content to help patients with chronic respiratory diseases monitor their symptoms and improve self-management. In addition to tailored information on their condition, participants will be encouraged to fill in daily data on their physical activity levels, symptomatology, use of rescue medication and mood. In children under 12 years, parents or caregivers will fill in this information. Patients will be asked to record their peak expiratory flow using an electronic peak flow meter twice daily. Every patient will be assigned a respiratory coach who will monitor patient during the study and whom the patients can contact at any time.
Behavioral: Happyair Ecosystem
Subjects in the CG will receive standard care consisting of periodic visitations at the Allergology or Paediatric Pulmonology Unit in their respective hospitals every 4 - 8 weeks according to their physician's criteria. In addition, patients and caregivers in both groups will receive one educational session regarding the correct use of their inhalers.
Happyair Ecosystem is a Smart Community for the integral care of patients with chronic or rare respiratory diseases such as Asthma, COPD or Alfa-1. Our community provides online \& offline training and resources in digital health and social care to patients, family, caregivers, healthcare professionals and researchers. Using our platform, all of our members will be able to connect in order to improve the health and well-being of patients, learn to manage self-care, ensure an active lifestyle, and contribute to the development of current and future research projects.
Differences in asthma control inter-group
Differences in asthma control (score) will be calculated according to the Asthma Control Test (ACT) in comparison with the control group. The ACT consists of five items that are rated according to a five-point scale where where 1 means poor control and 5 indicates better asthma control.
Time frame: 6 months
Differences in asthma control inter-group
Differences in asthma control (score) will be calculated according to the Asthma Control Test (ACT) in comparison with the control group. The ACT consists of five items that are rated according to a five-point scale where where 1 means poor control and 5 indicates better asthma control.
Time frame: 12 months
Inclusion rates (feasibility)
Total number of patients recruited which consented from those eligible
Time frame: Baseline
Completion rates
Total number of patients who completed the interventions from those who were recruited
Time frame: 12 months
Incidence of exacerbations
Number of exacerbations (events) in a year in both groups. Exacerbations will be defined as any worsening in asthma symptoms that requires an increase in the usual therapy, an unscheduled physician visit, treatment in the emergency room or hospitalization.
Time frame: 12 months
Changes in lung function (FEV1)
Lung function will be assessed by recording the Forced Expiratory Volume in the 1st second during a forced spirometry test.
Time frame: 6 Months
Changes in lung function (FEV1)
Lung function will be assessed by recording the Forced Expiratory Volume in the 1st second during a forced spirometry test.
Time frame: 12 Months
Changes in lung function (PEF)
Peak Expiratory flow will be recorded during a forced spirometry test to determine maximum expiratory flow as an indirect way of monitoring airway inflammation as well as asthma control over time.
Time frame: 6 Months
Changes in lung function (PEF)
Peak Expiratory flow will be recorded during a forced spirometry test to determine maximum expiratory flow as an indirect way of monitoring airway inflammation as well as asthma control over time.
Time frame: 12 Months
Plan to share: No
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