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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    60
  • sponsor
    Raquel Sebio
Updated on 17 September 2021

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 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.

Details
Condition Childhood Asthma, Asthma in Children
Treatment Happyair Ecosystem
Clinical Study IdentifierNCT04166344
SponsorRaquel Sebio
Last Modified on17 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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