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Completed

NCT Number: NCT04166344

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 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.

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Key information

Conditions

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Santa Creu i Sant Pau, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Happyair Ecosystem

Behavioral

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.

Primary outcomes

  1. Differences in asthma control inter-group

    Time frame: 6 months

    Differences in asthma control (score) will be calculated according to the Asthma Control Test (ACT) in comparison with the control group. The ACT consists of five items that are rated according to a five-point scale where where 1 means poor control and 5 indicates better asthma control.

  2. Differences in asthma control inter-group

    Time frame: 12 months

    Differences in asthma control (score) will be calculated according to the Asthma Control Test (ACT) in comparison with the control group. The ACT consists of five items that are rated according to a five-point scale where where 1 means poor control and 5 indicates better asthma control.

Secondary outcomes

  1. Inclusion rates (feasibility)

    Time frame: Baseline

    Total number of patients recruited which consented from those eligible

  2. Completion rates

    Time frame: 12 months

    Total number of patients who completed the interventions from those who were recruited

  3. Incidence of exacerbations

    Time frame: 12 months

    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.

  4. Changes in lung function (FEV1)

    Time frame: 6 Months

    Lung function will be assessed by recording the Forced Expiratory Volume in the 1st second during a forced spirometry test.

  5. Changes in lung function (FEV1)

    Time frame: 12 Months

    Lung function will be assessed by recording the Forced Expiratory Volume in the 1st second during a forced spirometry test.

  6. Changes in lung function (PEF)

    Time frame: 6 Months

    Peak Expiratory flow will be recorded during a forced spirometry test to determine maximum expiratory flow as an indirect way of monitoring airway inflammation as well as asthma control over time.

  7. Changes in lung function (PEF)

    Time frame: 12 Months

    Peak Expiratory flow will be recorded during a forced spirometry test to determine maximum expiratory flow as an indirect way of monitoring airway inflammation as well as asthma control over time.

Sponsors and collaborators

Lead sponsor

Lovexair Foundation

Other

Collaborators

  • Corporacion Parc Tauli
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari Parc Salut Mar
  • Hospital Vall d'Hebron

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 18, 2019
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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