Actively Recruiting

Phase Not Applicable
Age: 4Years +
All Genders
Healthy Volunteers
NCT06820593

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

Led by Ann & Robert H Lurie Children's Hospital of Chicago · Updated on 2025-09-10

80

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

Sponsors

A

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 4Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregivers must be at least 18 years old (parent or legal guardian)
  • Child has a diagnosis of asthma recorded in the electronic health record
  • Child is between 4 and 17 years old at recruitment
  • Child is prescribed inhaled corticosteroid or corticosteroid/long-acting beta agonist combination for daily use
  • Child has persistent or uncontrolled asthma based on NHLBI guidelines, including any of: more than 2 days per week with asthma symptoms, more than 2 days per week rescue medication use, more than 2 days per month nighttime awakenings, or more than 2 asthma episodes in past year requiring systemic corticosteroids
  • Child is a patient in Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH
Not Eligible

You will not qualify if you...

  • Caregiver has a smartphone not compatible with the Hailie® app
  • Patient is prescribed an inhaler medication not compatible with the Hailie electronic sensor
  • Caregiver cannot speak and understand English
  • Child has significant comorbid diagnoses such as cystic fibrosis, cyanotic heart disease, or bronchopulmonary dysplasia
  • Family has active Department of Child and Family Services involvement
  • Participant is enrolled in another asthma intervention study at enrollment
  • Child or sibling living at the same home was previously enrolled in this study
  • Consent is not obtained from parent or guardian
  • Parent or guardian does not pass the test of understanding at study enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

K

Kristin Kan, MD

CONTACT

O

Olivia Orr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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