Asthma in Children
Conditions
Brief summary
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.
Interventions
BEHAVIORALHappyair Ecosystem
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.
Sponsors
Hospital Vall d'Hebron
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Hospital Universitari Parc Salut Mar
Corporacion Parc Tauli
Lovexair Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
The statistical analyses will be performed by one researcher unaware of patient allocation
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* children between 6 and 18 years old; * diagnosis of moderate to severe persistent asthma according to the international guidelines * difficult to control asthma according to a scoring in the Asthma Control Questionnaire (ACQ) of 1.5 points or Asthma Control Test (ACT) ≤19; * access to internet and a smartphone, tablet or computer; * ability to understand and use the web-based platform (in children \<12 years the ability of the tutor or legal guardian); * informed consent (by the tutor or legal guardian)
Exclusion criteria
* patients who have had an exacerbation in the previous two weeks; * patients with intermittent asthma and/or well-controlled asthma according to the Asthma Control Questionnaire (ACQ) score of \<1.5 or Asthma Control Test (ACT) score ≥20; * any neurological or psychiatric condition that prevents patients to use adequately the platform.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in asthma control inter-group | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inclusion rates (feasibility) | Baseline | Total number of patients recruited which consented from those eligible |
| Completion rates | 12 months | Total number of patients who completed the interventions from those who were recruited |
| Incidence of exacerbations | 12 months | 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. |
| Changes in lung function (FEV1) | 6 Months | Lung function will be assessed by recording the Forced Expiratory Volume in the 1st second during a forced spirometry test. |
| Changes in lung function (PEF) | 6 Months | 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. |
Countries
Spain
Outcome results
None listed