Feasibility and Acceptability of the Propeller Monitoring System in Children With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The main hypothesis of this study is to see if children and adolescents with poorly
      controlled asthma will find the Propeller electronic monitoring device is feasible and
      acceptable, and will result in improved medication adherence and asthma control. Preliminary
      studies indicate that Propeller can improve medication adherence rates in children with
      asthma and reduce the number of days of reliever medication used. It also has been shown to
      reduce missed days of school and hospitalizations due to asthma exacerbations. The Propeller
      device is a sensor that fits over inhalers and uses Bluetooth connection to cell phones to
      remind patients to take their medication. It also records use of the controller and rescue
      inhalers, allowing for parents, physicians, and patients to get a fuller and more accurate
      picture of their adherence to treatment and severity of disease. With improved adherence,
      asthma control should improve, resulting in a decreased costs and use of services.
    

Detailed description: 
      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 Propeller devices (for controller and rescue inhalers), an App
      for their smartphone, and a free Propeller 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 Propeller 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. Propeller 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 Propeller 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
      Propeller's 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
      Propeller device.
    

Intervention name(s): Propeller EMD
Intervention type(s): Other
Intervention description(s): Propeller electronic monitoring device is a sensor that fits on top of inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.