Technology-Enhanced Asthma Care in Children at Clinic and Home Study

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Study ID
NCT06820593
Status
Recruiting
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Conditions

  • Asthma in Children
  • Chronic Diseases in Children

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Digital Asthma Intervention — BEHAVIORAL
    The intervention consists of two main components-the mHealth app and sensors that is part of the Adherium's Hailie® Solution-and the remote patient monitoring (RPM), conducted in this intervention by an asthma coordinator.
  • Comparison Group — BEHAVIORAL
    Participants in the comparison group will receive the sensors for their ICS inhalers and a limited version of the app that only collects the sensor information by Bluetooth, without app features, and sends the information to the Hailie web portal. This passive adherence data collection will allow for comparison of the two groups' adherence rates without the mHealth app self-management support or RPM.

Study Details

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.

Key Dates

Start date
Mar 14, 2025
Status verified
Sep 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Digital Asthma Intervention
    The intervention group will receive digital tools (mHealth app and sensors) and remote patient monitoring (RPM) assisted by an asthma coordinator, that supports an enhanced standard of care for their child's asthma. The mHealth intervention includes inhaler sensors on their rescue (SABA) and ICS inhaler and a mHealth app on the parent's smartphone. The asthma coordinator, as part of the implementation plan, will respond to information from the mHealth app and contact the participants about their adherence and asthma symptom control, following an algorithm aligned with NAEPP guidelines.
  • Active Comparator: Comparison
    The comparison group will also receive enhanced standard of asthma care. A research "control" version of the mHealth app will be downloaded to smartphones to allow for data collection from inhaler sensors, but the mHealth app will only silently transmit data to the web portal and not provide any app interaction or feedback to participants.

Primary Outcome Measure

Study Feasibility [ Time Frame: Baseline, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ann & Robert H Lurie Children's Hospital of ChicagoChicagoIllinois60611-

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By research site
Ann & Robert H Lurie Children's Hospital of Chicago· Chicago, IL

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