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

August 31, 2021 updated by: Raquel Sebio

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
        • Sub-Investigator:
          • Maria T Garriga-Baraut, MD
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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

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.
No Intervention: Control Group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in asthma control inter-group
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 6 months
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
Time Frame: 12 months
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)
Time Frame: Baseline
Total number of patients recruited which consented from those eligible
Baseline
Completion rates
Time Frame: 12 months
Total number of patients who completed the interventions from those who were recruited
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raquel Sebio

Collaborators

Hospital Vall d'Hebron
Hospital Santa Creu i Sant Pau
Hospital Universitari Parc Taulí
Hospital Universitari Parc Salut Mar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

November 13, 2019

First Submitted That Met QC Criteria

November 15, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

September 8, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LVX-ASTHMA-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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