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Asthma in ChildrenNCT04166344

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

A study testing Happyair Ecosystem in people with Asthma in Children, run by Lovexair Foundation at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Asthma in Children
What is being tested?
Happyair Ecosystem
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesSpain
Study dates
1 Sep 2021to 30 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

4 sites in 1 country.

Spain4 sites

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Santa Creu i Sant Pau

    Barcelona, Barcelona, 08041

  • Hospital Universitari Parc Taulí

    Sabadell, Barcelona, 08208

Other trials in Spain

About this study

Official 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

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.

Being tested
Happyair Ecosystem

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Happyair EcosystemBehavioural

    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.

Study groups in NCT04166344
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants 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.
Receives: Behavioral: Happyair Ecosystem
Control GroupNo interventionSubjects 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in asthma control inter-group

    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.

    Measured: 6 months

  2. Differences in asthma control inter-group

    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.

    Measured: 12 months

Secondary outcomes (7)

  1. Inclusion rates (feasibility)

    Total number of patients recruited which consented from those eligible

    Measured: Baseline

  2. Completion rates

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

    Measured: 12 months

  3. 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.

    Measured: 12 months

  4. Changes in lung function (FEV1)

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

    Measured: 6 Months

  5. Changes in lung function (FEV1)

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

    Measured: 12 Months

  6. Changes in lung function (PEF)

    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.

    Measured: 6 Months

  7. Changes in lung function (PEF)

    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.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2019
  2. Study start1 Sep 2021
  3. Primary completion30 May 2023
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04166344
Sponsor's protocol ID
LVX-ASTHMA-2019
Status last verified
Oct 2024
First submitted
13 Nov 2019
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carvajal-Uruena I, Garcia-Marcos L, Busquets-Monge R, Morales Suarez-Varela M, Garcia de Andoin N, Batlles-Garrido J, Blanco-Quiros A, Lopez-Silvarrey A, Garcia-Hernandez G, Guillen-Grimaj F, Gonzalez-Diaz C, Bellido-Blasco J. [Geographic variation in the prevalence of asthma symptoms in Spanish children and adolescents. International Study of Asthma and Allergies in Childhood (ISAAC) Phase 3, Spain]. Arch Bronconeumol. 2005 Dec;41(12):659-66. doi: 10.1016/s1579-2129(06)60333-9. Spanish.

    PubMed 16373042

  • Sullivan PW, Ghushchyan V, Kavati A, Navaratnam P, Friedman HS, Ortiz B. Trends in Asthma Control, Treatment, Health Care Utilization, and Expenditures Among Children in the United States by Place of Residence: 2003-2014. J Allergy Clin Immunol Pract. 2019 Jul-Aug;7(6):1835-1842.e2. doi: 10.1016/j.jaip.2019.01.055. Epub 2019 Feb 15.

    PubMed 30772478

  • Morita PP, Yeung MS, Ferrone M, Taite AK, Madeley C, Stevens Lavigne A, To T, Lougheed MD, Gupta S, Day AG, Cafazzo JA, Licskai C. A Patient-Centered Mobile Health System That Supports Asthma Self-Management (breathe): Design, Development, and Utilization. JMIR Mhealth Uhealth. 2019 Jan 28;7(1):e10956. doi: 10.2196/10956.

    PubMed 30688654

  • Ahmed S, Ernst P, Bartlett SJ, Valois MF, Zaihra T, Pare G, Grad R, Eilayyan O, Perreault R, Tamblyn R. The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial. J Med Internet Res. 2016 Dec 1;18(12):e313. doi: 10.2196/jmir.5866.

    PubMed 27908846

  • van Gaalen JL, Beerthuizen T, van der Meer V, van Reisen P, Redelijkheid GW, Snoeck-Stroband JB, Sont JK; SMASHING Study Group. Long-term outcomes of internet-based self-management support in adults with asthma: randomized controlled trial. J Med Internet Res. 2013 Sep 12;15(9):e188. doi: 10.2196/jmir.2640.

    PubMed 24028826

  • Rasmussen LM, Phanareth K, Nolte H, Backer V. Internet-based monitoring of asthma: a long-term, randomized clinical study of 300 asthmatic subjects. J Allergy Clin Immunol. 2005 Jun;115(6):1137-42. doi: 10.1016/j.jaci.2005.03.030.

    PubMed 15940125

  • Barrett MA, Humblet O, Marcus JE, Henderson K, Smith T, Eid N, Sublett JW, Renda A, Nesbitt L, Van Sickle D, Stempel D, Sublett JL. Effect of a mobile health, sensor-driven asthma management platform on asthma control. Ann Allergy Asthma Immunol. 2017 Nov;119(5):415-421.e1. doi: 10.1016/j.anai.2017.08.002.

    PubMed 29150069

  • Newhouse N, Martin A, Jawad S, Yu LM, Davoudianfar M, Locock L, Ziebland S, Powell J. Randomised feasibility study of a novel experience-based internet intervention to support self-management in chronic asthma. BMJ Open. 2016 Dec 28;6(12):e013401. doi: 10.1136/bmjopen-2016-013401.

    PubMed 28031210

  • Christakis DA, Garrison MM, Lozano P, Meischke H, Zhou C, Zimmerman FJ. Improving parental adherence with asthma treatment guidelines: a randomized controlled trial of an interactive website. Acad Pediatr. 2012 Jul-Aug;12(4):302-11. doi: 10.1016/j.acap.2012.03.006. Epub 2012 Jun 11.

    PubMed 22694878

  • Reddel HK, Bateman ED, Becker A, Boulet LP, Cruz AA, Drazen JM, Haahtela T, Hurd SS, Inoue H, de Jongste JC, Lemanske RF Jr, Levy ML, O'Byrne PM, Paggiaro P, Pedersen SE, Pizzichini E, Soto-Quiroz M, Szefler SJ, Wong GW, FitzGerald JM. A summary of the new GINA strategy: a roadmap to asthma control. Eur Respir J. 2015 Sep;46(3):622-39. doi: 10.1183/13993003.00853-2015. Epub 2015 Jul 23.

    PubMed 26206872

  • Sastre J, Olaguibel J, Vega JM, Del Pozo V, Picado C, Lopez Vina A. Cut-off points for defining asthma control in three versions of the Asthma Control Questionnaire. J Asthma. 2010 Oct;47(8):865-70. doi: 10.3109/02770903.2010.491149.

    PubMed 20846084

  • Juniper EF, Gruffydd-Jones K, Ward S, Svensson K. Asthma Control Questionnaire in children: validation, measurement properties, interpretation. Eur Respir J. 2010 Dec;36(6):1410-6. doi: 10.1183/09031936.00117509. Epub 2010 Jun 7.

    PubMed 20530041

  • Picado C, Badiola C, Perulero N, Sastre J, Olaguibel JM, Lopez Vina A, Vega JM; Covalair Investigator Group. Validation of the Spanish version of the Asthma Control Questionnaire. Clin Ther. 2008 Oct;30(10):1918-31. doi: 10.1016/j.clinthera.2008.10.005.

    PubMed 19014848

Questions about this trial

What is this clinical trial studying?

A study testing Happyair Ecosystem in people with Asthma in Children, run by Lovexair Foundation at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in asthma control inter-group (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04166344, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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