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

Not Applicable

Recruiting

• Conditions: Chronic Diseases in Children; Asthma in Children

• Registration Number: NCT06820593
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-02-05
• Study Start: 2025-03-14
• Study First Posted: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study Feasibility	Baseline, 12 months	Measured as the number and percentage of participants who complete the 12-month visit, between intervention and comparison group.

Secondary Outcome Measures

Name	Time	Method
Intervention Feasibility	12 months	Measured as the number and percentage of participants who synced their ICS sensor \>80% of enrolled days in the trial, comparing intervention and comparison groups.
Asthma Symptom Control	Baseline, 1, 3, 6, 9, and 12 months.	Investigators will use the validated childhood Asthma Control Test (c-ACT) for assessing asthma symptom control, or Asthma Control Test (ACT) if the child becomes 12 years old during the study.
Inhaled Corticosteroid Adherence	Continuously through the 12 months	Investigators will compare overall raw ICS adherence rates between intervention and comparison groups using two-sample tests for proportions of mean daily proportion of taken doses over prescribed doses of ICS by study month, measured by digital sensors on the ICS. Participants' data will be included if they had at least 1 ICS inhaler actuation during the trial.

Trial Locations

Locations (1)

Ann & Robert H Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States