A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma
A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma
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 Questionnaire 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.
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;

 -  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 ACQ
 score of <1.5;

 -  any neurological or psychiatric condition that prevents patients to use adequately the
 platform.