JMIR Publications

ABSTRACT

Background:

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

Objective:

This RCT will examine the effectiveness of Pulmonary Education and Asthma Knowledge Mobile Asthma Action Plan (PEAKmAAP) among adolescents with uncontrolled asthma. PEAKmAAP is an interactive mHealth asthma action plan (mAAP) smartphone application. We previously demonstrated feasibility of a PEAKmAAP for adolescents with asthma and now aim to test the application’s effectiveness compared to enhanced usual care (eUC) using a full-scale RCT. The study has 3 aims: 1) examine the effectiveness of PEAKmAAP in reducing asthma morbidity as measured by Asthma Control Test (ACT) score, healthcare utilization, medication use and lung function; 2) examine the effectiveness of PEAKmAAP on asthma self-efficacy and medication adherence; 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 PEAKmAAP-DS group will have sustained controlled at follow-up visits compared to PEAKmAAP alone or eUC.

Methods:

Using 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 Arkansas Children’s Hospital (ACH) or asthma care at ACH specialty clinics. At baseline, participants are randomly assigned to one of three groups: 1) PEAKmAAP alone, 2) PEAKmAAP with PCP data sharing (PEAKmAAP-DS), and 3) a enhanced usual care (eUC) group utilizing a smartphone application with daily non-asthma related notifications. Study procedures include a baseline, 3- and 12-month in-person visits and telephone visits at 6- and 9-months. In-person visits measure ACT score, lung function, and self-efficacy; telephone visits measure ACT score. Participants complete monthly online surveys to assess healthcare utilization and medication use.

Results:

Recruitment and data collection began in March 2019, and data collection concluded in May 2024.

Conclusions:

This 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 high-risk asthma populations Clinical Trial: Study registry clinicaltrials.gov trial number NCT03842033