Feasibility and Acceptability of the Hailie Monitoring System in Children With Persistent Asthma

This study is a prospective cohort study using a pre-/post-design.

The target population consists of children and adolescents 10-18 years old making an ED visit
or admitted to the hospital at Connecticut Children's Medical Center for an asthma
exacerbation.

All patients will receive two Hailie devices (for controller and rescue inhalers), an App for
their smartphone, and a free Hailie subscription, which provides access support and services,
and hardware and software updates. Only the children and adolescents involved with the study
will have the app on their phone. The parents will not put the Hailie app on their phone.
Families will be asked to share the study information with their primary care provider and
will be provided with an introductory letter to bring to the provider, if they so choose.

Data collection will begin at enrollment and will continue through the three-month follow-up
period. Adherium provides the option of continuous monitoring and data collection beyond
study cessation.

Data uploads to the portal occur automatically for patients and caregivers who have installed
the Hailie App on their smartphone. Additionally, patients' primary-care providers will
receive a password allowing them to track and access participants' dashboard. Patients will
bring a letter to their primary-care provider explaining that they are part of a study of
Adherium's Hailie device, and receive instructions on how to view the dashboard and adherence
data.

At enrollment, participants and parents will complete the Test of Adherence to Inhalers
(TAI), Asthma Control Test (ACT) and PedsQL, along with providing baseline medical
history/asthma history data and sociodemographic. The TAI, ACT and PedsQL surveys will again
be completed one and three months post enrollment information. Additionally, participants
will answer an adapted AMDAT survey that will be used to provide acceptability data about the
Hailie device.

Inclusion Criteria:

1. Children in the ED or inpatient setting presenting with an asthma exacerbation between
10-18 years old

2. History of persistent asthma (defined as prescribed a controller medication)

3. Both the child and primary caregiver/parent have access to a cell phone with an
activated number

4. Ability of child's parent/legal guardian to understand and the willingness to sign a
written informed consent document.

Exclusion Criteria:

1. Child or parent has no access to a personal cell phone.

2. The child has another chronic pulmonary condition (for example, cystic fibrosis)

3. Having any chronic condition that could affect the child's ability to participate in
the study (examples: cancer, autism, or cerebral palsy)

4. The subject has an inhaler medication besides the following, given these are the
current medications compatible with the Hailie device sleeve.

i. Advair HFA ii. Flovent HFA iii. QVAR HFA iv. Symbicort HFA v. Ventolin HFA vi.
ProAir HFA