Comparing a Guideline-Based Mobile Health Intervention Versus Usual Care for High-Risk Adolescents With Asthma: Protocol of a Randomized Controlled Trial.

backgroundMobile health (mHealth) technology has the ability to integrate personalized health management into patients' daily routines. In prior investigations of mHealth apps for asthma, patient satisfaction and acceptability have been high. However, rigorous randomized controlled trials (RCTs) examining their effectiveness are sparse; the majority of mHealth asthma apps lack personalization and real-time feedback and fail to include at-risk pediatric populations, and many previous studies are not randomized.

objectiveThis full-scale RCT will examine the effectiveness of the Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan (PEAKmAAP), an interactive mHealth asthma action plan (mAAP) smartphone app, among adolescents compared to enhanced usual care (eUC). The study has 3 aims: (1) examine the effectiveness of PEAKmAAP in reducing asthma morbidity, as measured by the Asthma Control Test (ACT) score, health care use, medication use, and lung function; (2) examine the effectiveness of PEAKmAAP in asthma self-efficacy and medication adherence; and (3) examine the impact of sharing PEAKmAAP-generated data with the primary care provider (PCP) for a subset of enrolled subjects. We hypothesize that the PEAKmAAP groups will experience reduced asthma morbidity compared to the eUC group. Furthermore, we hypothesize that PCP data sharing is expected to enhance PCP prescribing patterns and that more adolescents in the Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan with data sharing (PEAKmAAP-DS) group will have sustained controlled at follow-up visits compared to PEAKmAAP alone or eUC.

methodsUsing a 3-arm RCT lasting 12 months, we will assess the effectiveness of PEAKmAAP in reducing morbidity among 432 adolescents (age 12-20 years). The study population includes adolescents with uncontrolled symptoms who receive primary care at the Arkansas Children's Hospital (ACH) or asthma care at ACH specialty clinics. At baseline, participants are randomly assigned to 1 of 3 groups: (1) PEAKmAAP group, (2) PEAKmAAP-DS group, and (3) eUC group using a smartphone app with daily non-asthma-related notifications. Study procedures will include baseline, 3-month, and 12-month in-person visits and telephone visits at 6 and 9 months. In-person visits will measure the ACT score, lung function, and self-efficacy; telephone visits will measure the ACT score. Participants will complete monthly online surveys to assess health care use and medication use.

resultsRecruitment and data collection began in March 2019, and data collection concluded in May 2024. Full data analysis began in December 2024.

conclusionsThis RCT aims to examine the effectiveness of a mAAP with real-time feedback and PCP data sharing. The study addresses existing gaps in knowledge regarding implementation of a mAAP for high-risk adolescents and has the potential to serve as a model for other populations at high risk for asthma.

trial registrationClinicalTrials.gov NCT03842033; https://clinicaltrials.gov/study/NCT03842033. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/69903.