Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06820593

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

Technology-Enhanced Asthma Care in Children at Clinic and Home (TEACCCH) Study (Aim 2): A Feasibility Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
Sex
All
Age
4 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDigital Asthma InterventionThe 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.
BEHAVIORALComparison GroupParticipants 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.

Timeline

Start date
2025-03-14
Primary completion
2027-01-01
Completion
2027-01-01
First posted
2025-02-11
Last updated
2025-09-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06820593. Inclusion in this directory is not an endorsement.