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

Asthma in Children Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04166344
• Other study ID #: LVX-ASTHMA-2019
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: August 2021
• Source: Lovexair Foundation
• Contact: Raquel Sebio-Garcia, PhD
• Phone: +34679336288
• Email: raquelsebio[@]lovexair.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitari Parc Taulí	Sabadell	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Raquel Sebio	Hospital Santa Creu i Sant Pau, Hospital Universitari Parc Salut Mar, Hospital Universitari Parc Taulí, Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Ahmed S, Ernst P, Bartlett SJ, Valois MF, Zaihra T, Paré 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. — View Citation

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. — View Citation

Carvajal-Urueña I, García-Marcos L, Busquets-Monge R, Morales Suárez-Varela M, García de Andoin N, Batlles-Garrido J, Blanco-Quirós A, López-Silvarrey A, García-Hernández G, Guillén-Grimaj F, González-Díaz 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. Spanish. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Picado C, Badiola C, Perulero N, Sastre J, Olaguíbel JM, López Viña 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. Erratum in: Clin Ther. 2014 Oct 1;36(10):1480. — View Citation

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. — View Citation

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. Review. — View Citation

Sastre J, Olaguibel J, Vega JM, Del Pozo V, Picado C, Lopez Viña 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Inclusion rates (feasibility)	Total number of patients recruited which consented from those eligible	Baseline
Secondary	Completion rates	Total number of patients who completed the interventions from those who were recruited	12 months
Secondary	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