Improving Asthma Care Together (IMPACT) mobile health intervention for school-age children with asthma and their parents: a pilot randomised controlled trial study protocol

Jennifer Sonney, Teresa Ward, Hilaire J Thompson, Julie A Kientz, Chris Segrin, Jennifer Sonney, Teresa Ward, Hilaire J Thompson, Julie A Kientz, Chris Segrin

Abstract

Introduction: Asthma is an incurable, lifelong condition that places children at increased risk for exacerbation, hospitalisation and school absences. Most paediatric asthma interventions target parents alone and are overly prescriptive. Improving Asthma Care Together (IMPACT) is a novel shared management system comprised of a mobile health (mHealth) application, symptom watch and tailored health intervention that pairs parent and child together as an asthma management team. IMPACT helps families monitor asthma status, tailor asthma management strategies and facilitate intentional transition of asthma management to the child. The purpose of this study is to determine the feasibility, acceptability and preliminary efficacy of the IMPACT intervention.

Methods and analysis: This pilot randomised controlled trial will recruit 60 children with asthma (7-11 years) and one parent. All parent-child dyads will complete data collection sessions at baseline, postintervention and follow-up. Dyads randomised to the intervention group (IMPACT) will complete the 8-week intervention comprised of weekly activities including symptom monitoring, goal setting and progress monitoring. Dyads randomised to the control group will receive usual care but then be provided access to IMPACT at the end of the study. Feasibility will be measured by the proportion of eligible dyads enrolled and retained. Acceptability of IMPACT will be assessed using the Acceptability of Intervention Measure, the System Usability Scale and a semistructured interview. Preliminary efficacy is determined based on change in primary outcomes, parent-reported and child-reported asthma responsibility and asthma self-efficacy scores, from baseline.

Ethics and dissemination: This study has been approved by the University of Washington Institutional Review Board; study ID: STUDY00010461. Participants gave informed consent to participate in the study before taking part. Study results will be disseminated in peer-reviewed journals and scientific conferences. A lay summary will be provided to study participants.

Trial registration number: NCT04908384 (ClinicalTrials.gov identifier).

Keywords: asthma; clinical trials; health informatics.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
SPIRIT Schedule of enrolment, interventions and assessment. C, child; I, intervention group only; P, parent; QOL, quality of life; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trial; X, all participants.

References

    1. Centers for Disease Control and Prevention . Most recent national asthma data Atlanta. GA: US Department of Health and Human Services, 2019.
    1. National asthma education prevention program (NAEPP) . Expert panel report 3 (EPR-3): guidelines for the diagnosis and management of Asthma–Summary report 2007. J Allergy Clin Immunol 2007;120:S94–138. 10.1016/j.jaci.2007.09.029
    1. Celano MP, Linzer JF, Demi A, et al. . Treatment adherence among low-income, African American children with persistent asthma. J Asthma 2010;47:317–22. 10.3109/02770900903580850
    1. Grainge CL, Lau LCK, Ward JA, et al. . Effect of bronchoconstriction on airway remodeling in asthma. N Engl J Med 2011;364:2006–15. 10.1056/NEJMoa1014350
    1. Brand PLP, Mäkelä MJ, Szefler SJ, et al. . Monitoring asthma in childhood: symptoms, exacerbations and quality of life. Eur Respir Rev 2015;24:187–93. 10.1183/16000617.00003614
    1. McQuaid EL, Kopel SJ, Klein RB, et al. . Medication adherence in pediatric asthma: reasoning, responsibility, and behavior. J Pediatr Psychol 2003;28:323–33. 10.1093/jpepsy/jsg022
    1. Elkout H, Helms PJ, Simpson CR, et al. . Adequate levels of adherence with controller medication is associated with increased use of rescue medication in asthmatic children. PLoS One 2012;7:e39130–6. 10.1371/journal.pone.0039130
    1. Buford TA. School-Age children with asthma and their parents: relationships with health care providers. Issues Compr Pediatr Nurs 2005;28:153–62. 10.1080/01460860500227564
    1. Olson LM, Radecki L, Frintner MP, et al. . At what age can children report dependably on their asthma health status? Pediatrics 2007;119:e93–102. 10.1542/peds.2005-3211
    1. Rebok G, Riley A, Forrest C, et al. . Elementary school-aged children's reports of their health: a cognitive interviewing study. Qual Life Res 2001;10:59–70. 10.1023/A:1016693417166
    1. Riley AW. Evidence that school-age children can self-report on their health. Ambul Pediatr 2004;4:371–6. 10.1367/A03-178R.1
    1. Kieckhefer GM, Trahms CM. Supporting development of children with chronic conditions: from compliance toward shared management. Pediatr Nurs 2000;26:354–63.
    1. Sonney JT, Insel KC. Reformulating the common sense model of self-regulation: toward parent-child shared regulation. Nurs Sci Q 2016;29:154–9. 10.1177/0894318416630091
    1. Malerstein AJ, Ahern MM. Piaget's stages of cognitive development and adult character structure. Am J Psychother 1979;33:107–18. 10.1176/appi.psychotherapy.1979.33.1.107
    1. Newton JT, Harrison V. The cognitive and social development of the child. Dent Update 2005;32:33–8. 10.12968/denu.2005.32.1.33
    1. Marcano Belisario JS, Huckvale K, Greenfield G, et al. . Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev 2013;11:CD010013. 10.1002/14651858.CD010013.pub2
    1. Bender BG, Cvietusa PJ, Goodrich GK, et al. . Pragmatic trial of health care technologies to improve adherence to pediatric asthma treatment: a randomized clinical trial. JAMA Pediatr 2015;169:317–23. 10.1001/jamapediatrics.2014.3280
    1. Vasbinder EC, Janssens HM, Rutten-van Mölken MPMH, et al. . e-Monitoring of asthma therapy to improve compliance in children using a real-time medication monitoring system (RTMM): the e-MATIC study protocol. BMC Med Inform Decis Mak 2013;13:38. 10.1186/1472-6947-13-38
    1. Welsh EJ, Hasan M, Li P. Home-based educational interventions for children with asthma. Cochrane Database Syst Rev 2011;10:CD008469. 10.1002/14651858.CD008469.pub2
    1. Shegog R, Bartholomew LK, Parcel GS, et al. . Impact of a computer-assisted education program on factors related to asthma self-management behavior. J Am Med Inform Assoc 2001;8:49–61. 10.1136/jamia.2001.0080049
    1. Chiang L-C, Huang J-L, Yeh K-W, et al. . Effects of a self-management asthma educational program in Taiwan based on PRECEDE-PROCEED model for parents with asthmatic children. J Asthma 2004;41:205–15. 10.1081/JAS-120026078
    1. Ekim A, Ocakci AF. Perceptions of parents and children regarding asthma management responsibilities. J Spec Pediatr Nurs 2013;18:289–96. 10.1111/jspn.12037
    1. Sonney JT, Gerald LB, Insel KC. Parent and child asthma illness representations: a systematic review. J Asthma 2016;53:510–6. 10.3109/02770903.2015.1116088
    1. Butz AM, Walker JM, Pulsifer M, et al. . Shared decision making in school age children with asthma. Pediatr Nurs 2007;33:111–6.
    1. Brown N, Gallagher R, Fowler C, et al. . The role of parents in managing asthma in middle childhood: an important consideration in chronic care. Collegian 2010;17:71–6. 10.1016/j.colegn.2010.04.006
    1. Sonney J, Cho Emily (Enubi), Zheng Q, et al. . Refinement of a parent-child shared asthma management mHealth APP: human centered design study (Preprint). JMIR Pediatr Parent 2021. 10.2196/34117
    1. Sonney J, Duffy M, Hoogerheyde LX, et al. . Applying Human-Centered design to the development of an asthma essentials kit for school-aged children and their parents. J Pediatr Health Care 2019;33:169–77. 10.1016/j.pedhc.2018.07.008
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Harris PA, Taylor R, Thielke R, et al. . Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. 10.1016/j.jbi.2008.08.010
    1. Kenny DA, Kashy DA, Cook WL. Dyadic data analysis. New York, NY: The Guildford Press, 2006.
    1. Ackerman RA, Kenny DA. APIMPowerR: An interactive tool for Actor-Partner Interdependence Model power analysis [computer software], 2016. Available: [Accessed 25 Apr 2017].
    1. McQuaid EL, Penza-Clyve SM, Nassau JH, et al. . The asthma responsibility questionnaire: patterns of family responsibility for asthma management. Children's Health Care 2001;30:183–99. 10.1207/S15326888CHC3003_2
    1. Bursch B, Schwankovsky L, Gilbert J, et al. . Construction and validation of four childhood asthma self-management scales: parent barriers, child and parent self-efficacy, and parent belief in treatment efficacy. Journal of Asthma 1999;36:115–28. 10.3109/02770909909065155
    1. Liu AH, Zeiger R, Sorkness C, et al. . Development and cross-sectional validation of the childhood asthma control test. J Allergy Clin Immunol 2007;119:817–25. 10.1016/j.jaci.2006.12.662
    1. Liu AH, Zeiger RS, Sorkness CA, et al. . The childhood asthma control test: retrospective determination and clinical validation of a cut point to identify children with very poorly controlled asthma. J Allergy Clin Immunol 2010;126:e1:267–73. 10.1016/j.jaci.2010.05.031
    1. Expert Panel Working Group of the National Heart, Lung, and Blood Institute (NHLBI) administered and coordinated National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC), Cloutier MM, Baptist AP, et al. . 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol 2020;146:1217–70. 10.1016/j.jaci.2020.10.003
    1. Cohen JL, Mann DM, Wisnivesky JP, et al. . Assessing the validity of self-reported medication adherence among inner-city asthmatic adults: the medication adherence report scale for asthma. Ann Allergy Asthma Immunol 2009;103:325–31. 10.1016/S1081-1206(10)60532-7
    1. Sonney J, Insel KC, Segrin C, et al. . Association of asthma illness representations and reported controller medication adherence among school-aged children and their parents. J Pediatr Health Care 2017;31:703–12. 10.1016/j.pedhc.2017.06.002
    1. Kosse RC, Koster ES, Kaptein AA, et al. . Asthma control and quality of life in adolescents: the role of illness perceptions, medication beliefs, and adherence. J Asthma 2020;57:1145–54. 10.1080/02770903.2019.1635153
    1. Tiggelman D, van de Ven MOM, van Schayck OCP, et al. . Longitudinal associations between asthma control, medication adherence, and quality of life among adolescents: results from a cross-lagged analysis. Qual Life Res 2015;24:2067–74. 10.1007/s11136-015-0945-3
    1. Juniper EF, Guyatt GH, Feeny DH, et al. . Measuring quality of life in children with asthma. Qual Life Res 1996;5:35–46. 10.1007/BF00435967
    1. Juniper EF, Guyatt GH, Feeny DH, et al. . Measuring quality of life in the parents of children with asthma. Qual Life Res 1996;5:27–34. 10.1007/BF00435966
    1. Epstein NB, Baldwin LM, Bishop DS. The McMaster family assessment DEVICE*. J Marital Fam Ther 1983;9:171–80. 10.1111/j.1752-0606.1983.tb01497.x
    1. Bihun JT, Wamboldt MZ, Gavin LA, et al. . Can the family assessment device (FAD) be used with school aged children? Fam Process 2002;41:723–31. 10.1111/j.1545-5300.2002.00723.x
    1. Broadbent E, Petrie KJ, Main J, et al. . The brief illness perception questionnaire. J Psychosom Res 2006;60:631–7. 10.1016/j.jpsychores.2005.10.020
    1. Valero-Moreno S, Lacomba-Trejo L, Casaña-Granell S, et al. . Psychometric properties of the questionnaire on threat perception of chronic illnesses in pediatric patients. Rev Lat Am Enfermagem 2020;28:e3242. 10.1590/1518-8345.3144.3242
    1. Horne R, Weinman J, Hankins M. The beliefs about medicines questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health 1999;14:1–24. 10.1080/08870449908407311
    1. Yilmaz O, Eroglu N, Ozalp D, et al. . Beliefs about medications in asthmatic children presenting to emergency department and their parents. J Asthma 2012;49:282–7. 10.3109/02770903.2011.654021
    1. Weiner BJ, Lewis CC, Stanick C, et al. . Psychometric assessment of three newly developed implementation outcome measures. Implement Sci 2017;12:108. 10.1186/s13012-017-0635-3
    1. Brooke J. System usability scale : improving the user experience: US. Department of Health & Human Services, 2018. Available: [Accessed 17 Jun 2018].
    1. Kenny DA, Cook W. Partner effects in relationship research: conceptual issues, analytic difficulties, and illustrations. Pers Relatsh 1999;6:433–48. 10.1111/j.1475-6811.1999.tb00202.x
    1. International Committee of Medical Journal Editors . Defining the role of authors and contributors, 2021. Available: [Accessed 20 Dec 2021].

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa