NCT04166344

A MHealth Intervention to Improve Symptom Control in Children and Adolescents with Difficult-to-control Asthma

Completed NA Last updated 31 October 2024

What this trial tests

NA trial testing Happyair Ecosystem in Asthma in Children in 60 participants. Completed in 30 May 2024.

Timeline

1 September 2021

Primary endpoint
30 May 2023

30 May 2024

Quick facts

Lead sponsor	Lovexair Foundation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	60
Start date	1 September 2021
Primary completion	30 May 2023
Estimated completion	30 May 2024
Sites	4 locations across Spain

Drugs / interventions tested

• Happyair Ecosystem

Conditions studied

• Asthma in Children — all drugs for Asthma in Children →

Sponsor

Lovexair Foundation

Who can join

Adults 6 to 18, any sex, with Asthma in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Digital therapeutics in the clinic.
   Phan P, Mitragotri S, Zhao Z. · · 2023 · cited 39× · PMID 37476062 · DOI 10.1002/btm2.10536