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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of a Web-based, Digital Health Platform Combining Social Care and Respiratory Coach Support to Improve Adherence to Treatment and Symptom Control in Children and Adolescents With Difficult-to-control Asthma

Conditions
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Asthma in Children

Intervention / Treatment
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* Behavioral: Happyair Ecosystem


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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 and to fulfil the Asthma Control Questionnaire once a week. They will also have a device connected to their inhaler to record adherence to the medical treatment and will get daily reminders in their smartphones. Every patient will be assigned a respiratory coach who will monitor patient during the study and whom the patients can contact at any time. | Behavioral: Happyair Ecosystem<br>* 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.<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in asthma control inter-group | We will assess differences in asthma control (score) according to the Asthma Control Questionnaire (ACQ) in comparison with the control group. The ACQ consists of seven items that are rated according to a seven-point scale where where 0 means no impairment and 6 indicates maximum impairment. | 6 months | 
| Differences in asthma control inter-group | We will assess differences in asthma control (score) according to the Asthma Control Questionnaire (ACQ) in comparison with the control group. The ACQ consists of seven items that are rated according to a seven-point scale where where 0 means no impairment and 6 indicates maximum impairment. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in asthma control intra-group for the intervention group | Changes in asthma control (score) according to the Asthma Control Questionnaire pre to post-intervention (Intervention Group). The ACQ consists of seven items that are rated according to a seven-point scale where where 0 means no impairment and 6 indicates maximum impairment. | 6 months | 
| Changes in asthma control intra-group for the intervention group | Changes in asthma control (score) according to the Asthma Control Questionnaire at follow-up (Intervention Group). The ACQ consists of seven items that are rated according to a seven-point scale where where 0 means no impairment and 6 indicates maximum impairment. | 12 months | 
| Changes in asthma control intra-group for the control group | Changes in asthma control (score) according to the Asthma Control Questionnaire post-intervention (Control Group). The ACQ consists of seven items that are rated according to a seven-point scale where where 0 means no impairment and 6 indicates maximum impairment. | 6 months | 
| Changes in asthma control intra-group for the control group | Changes in asthma control (score) according to the Asthma Control Questionnaire pre to post-intervention (Control Group). The ACQ consists of seven items that are rated according to a seven-point scale where where 0 means no impairment and 6 indicates maximum impairment. | 12 months | 
| Inclusion rates (feasibility) | Total number of patients recruited which consented from those eligible | Baseline | 
| Completion rates | Total number of patients who completed the interventions from those who were recruited | 12 months | 
| Incidence of exacerbations | 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. | 12 months |