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

NCT06820593 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-10

No results posted yet for this study

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

  • Asthma in Children
  • Chronic Diseases in Children

Interventions

BEHAVIORAL

Digital Asthma Intervention

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.

BEHAVIORAL

Comparison Group

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.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Ann & Robert H Lurie Children's Hospital of Chicago

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06820593 on ClinicalTrials.gov