The Study is Enrolling Kids From 8 to 17 Years Old. The BreathSmart Device Attaches to the Inhaler to Measure Adherence.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Non-adherence to controller medication is a common problem in children with Asthma, resulting
      in overuse of reliever medication, increased asthma symptoms, more frequent Asthma attacks,
      and increased emergency room visits and hospital admissions. Additionally, current absence of
      a gold standard to measure adherence forces clinicians and researchers to rely on
      patient-self report, which is notoriously inaccurate, to support clinical decision making.
      Many young patients suffer from both intentional and non-intentional non-adherence, thus an
      appropriate intervention must address both types. Current studies using electronic monitoring
      devices (EMDs) primarily focus on non-intentional non-adherence through reminder systems and
      thus are limited in their ability to engage patients for long-term behavior change.

      This trial addresses an important knowledge gap by evaluating whether EMDs with a combination
      of reminder system and patient education can prove to be effective in increasing adherence
      rates and can be used in clinical practice to achieve better asthma control and outcomes
      through improved patient and clinician engagement.
    

Detailed description: 
      This is a prospective, randomized, controlled study of children with persistent asthma who
      are managed on daily inhaled corticosteroids (ICS). 75 children will be randomized 2:1 into
      one of two arms:

        -  50 children will be randomized to BreatheSmart, comprised of:

             -  BreatheSmart mobile application that tracks medication usage and sends real time
                reminders

             -  HeroTracker sensor that counts dosage and monitors real-time medication adherence

             -  CoheroConnect provider portal that allows the Investigator to monitor real-time
                adherence and to provide targeted outreach to children with low adherence
                (intervention arm)

        -  25 children will be randomized to "standard of care"(control arm). These patients are
           reminded to adhere to the prescribed standard of care therapy provided by their
           clinician during their clinical encounters and when the family calls to report an
           illness.
    

Intervention name(s): BreatheSmart System; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders
HeroTracker sensor that counts dosage and monitors real-time medication adherence
CoheroConnect provider portal that allows the Investigator to monitor adherence; These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to one of two arms:
BreathSmart system
Standard of Care
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Asthma