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

Lovexair Foundation

Status: Completed

Conditions: Asthma in Children

Treatments: Behavioral: Happyair Ecosystem

Study type: Interventional

Funder types: Other

Identifiers

NCT04166344

LVX-ASTHMA-2019

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Behavioral: Happyair Ecosystem

Control Group

No Intervention group

Description:

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.