iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The goal of this study is to determine whether a sensor-enabled, clinically integrated,
      mobile health asthma program can improve asthma outcomes among 4-17 year old children with
      moderate-to-severe asthma.
    

Detailed description: 
      Primary Aims:

        -  Assess whether asthma control in patients enrolled in the intervention arm improved in
           comparison to the control arm through the (ACT) measurement tool.

        -  Assess healthcare utilization (asthma-related ED visits and hospitalizations,
           asthma-related oral corticosteroid use) obtained through electronic medical record and
           parent report.

      Secondary Aims:

      Investigators will use parent-report surveys of the following psycho-social outcome measures:

        -  Days missed from school due to asthma; 2) pediatric asthma-related quality of life
           (PACQLQ); and 3) Parental Asthma Management Self-Efficacy (PAMSE).

        -  Enhance parental management through improved inhaler use. The investigators will use the
           Propeller Sensor Platform (referenced as Remote Health Management Platform) to allow
           parents to track their child's ICS and SABA inhaler use daily. The Platform also will
           have specific educational messaging to help parents and their children achieve adherence
           to their prescribed plan. This constant feedback and reinforcement may lead to improved
           asthma control therefore reducing frequency and severity of asthma exacerbations. The
           investigators will also be assessing the factors associated with the feasibility and
           sustainability of the Propeller Sensor Platform by observing trends in utilization.
           Utilization and drop-off will be measured by monitoring use of the inhalers and periodic
           surveys of families.

        -  Improve management by the healthcare team. The investigators will use the Remote Health
           Management Platform to integrate inhaler use data into a web portal that the physician's
           office can access. Through the development of this interface, the Propeller Sensor
           Platform will be able to provide inhaler use feedback to healthcare teams.

      Types of feedback:

        -  Emergency Management: data on inhaled corticosteroids (ICS) and short-acting
           beta-agonist (SABA) use

        -  Long-term Management: data on ICS and SABA use. This interface will include data on both
           ICS and SABA inhaler use. The interface will also have flags to notify the office of
           under or overuse of inhalers, with a protocol in place to reach out to patients. The
           investigators will also be assessing the factors associated with the feasibility and
           sustainability of the Remote Health Management Platform by the healthcare team. This
           will be done by weekly contact with the healthcare team, rapid cycle improvement of the
           web portal, and written assessments.
    

Intervention name(s): Remote Health Management Sensor Platform
Intervention type(s): Device
Intervention description(s): The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
Other intervention name(s): Reciprocal Labs; Propeller Health Systems
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care