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

Abstract

IntroductionAsthma 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 analysisThis 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 disseminationThis 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 numberNCT04908384 (ClinicalTrials.gov identifier).