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
Qualifiers
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
Treatments tested in this trial
- Digital Asthma Intervention
- Comparison Group
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov