A randomized controlled trial with parent-child pairs of children with persistent or uncontrolled asthma. An intervention group (n=40 parent-child pairs) will receive the mobile health (mHealth) app and digital sensors with enhanced support from a population health manager role, hereinafter referred to as an asthma coordinator, to provide remote patient monitoring (RPM). A comparison group (n=40 parent-child pairs) will receive the mHealth app and sensors without RPM support to silently collect inhaler use information without mHealth app features. The focus of this project is to evaluate the feasibility and acceptability of delivering a digital intervention for pediatric asthma with RPM in the outpatient setting.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
80
The intervention consists of two main components-the mHealth app and sensors that is part of the Adherium's Hailie® Solution-and the remote patient monitoring (RPM), conducted in this intervention by an asthma coordinator.
Participants in the comparison group will receive the sensors for their ICS inhalers and a limited version of the app that only collects the sensor information by Bluetooth, without app features, and sends the information to the Hailie web portal. This passive adherence data collection will allow for comparison of the two groups' adherence rates without the mHealth app self-management support or RPM.
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGStudy Feasibility
Measured as the number and percentage of participants who complete the 12-month visit, between intervention and comparison group.
Time frame: Baseline, 12 months
Intervention Feasibility
Measured as the number and percentage of participants who synced their ICS sensor \>80% of enrolled days in the trial, comparing intervention and comparison groups.
Time frame: 12 months
Asthma Symptom Control
Investigators will use the validated childhood Asthma Control Test (c-ACT) for assessing asthma symptom control, or Asthma Control Test (ACT) if the child becomes 12 years old during the study.
Time frame: Baseline, 1, 3, 6, 9, and 12 months.
Inhaled Corticosteroid Adherence
Investigators will compare overall raw ICS adherence rates between intervention and comparison groups using two-sample tests for proportions of mean daily proportion of taken doses over prescribed doses of ICS by study month, measured by digital sensors on the ICS. Participants' data will be included if they had at least 1 ICS inhaler actuation during the trial.
Time frame: Continuously through the 12 months
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