Technology-Enhanced Asthma Care in Children at Clinic and Home Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4+
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The child (patient) has a diagnosis of asthma associated with a clinic visit in the electronic health record
The child is between the ages of 4-17 years old at the time of recruitment
The study is interested in the self-management of asthma by caregivers, whom are still primarily responsible for their child's chronic disease management.
Children younger than 4 years old will not be included in this study as the diagnosis of asthma is typically difficult to confirm in younger ages.
Disqualifiers
The caregiver has a smartphone that is not compatible with the Hailie® app.
The patient is prescribed a controller (preventive) or rescue inhaler medication to which the Hailie electronic sensor cannot affix.
The caregiver is unable to speak and understand English.
The child has clinically significant, comorbid diagnoses, such as cystic fibrosis, cyanotic heart disease, or bronchopulmonary dysplasia, that could interact with their assessment of asthma-related measures.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Asthma Intervention
BehavioralThe 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.
Comparison Group
BehavioralParticipants 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Digital Asthma InterventionExperimental treatment 1 intervention
Group B: ComparisonActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Study Feasibility
Measured as the number and percentage of participants who complete the 12-month visit, between intervention and comparison group.
Time frame
Baseline, 12 monthsSecondary outcomes
1
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 months2
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.3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov