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

NCT ID: NCT06820593

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-14
• Study Completion Date: 2027-01-31

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.

Conditions

Asthma in Children; Chronic Diseases in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Digital Asthma Intervention

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Comparison Group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Caregivers must be at least 18 years old (defined as parent or legal guardian)

2. The child (patient) has a diagnosis of asthma associated with a clinic visit in the electronic health record

3. The child is between the ages of 4-17 years old at the time of recruitment

1. The study is interested in the self-management of asthma by caregivers, whom are still primarily responsible for their child's chronic disease management.

2. Children younger than 4 years old will not be included in this study as the diagnosis of asthma is typically difficult to confirm in younger ages.

4. The child is prescribed inhaled corticosteroid or corticosteroid/long-acting beta agonist combination for daily use. The patient can have an inhaled corticosteroid/long-acting beta agonist for both daily preventive and rescue use, as in Single Maintenance and Reliever Therapy (SMART).

5. Persistent or un controlled asthma based on NHLBI guidelines40; Any 1 of the following:

1. In past month, >2 days per week with asthma symptoms

2. >2 days per week with rescue medication use

3. >2 days per month with nighttime awakenings (for children who are not taking a controller asthma medication) OR >2 days per month with nighttime awakenings (for children who are currently taking a controller asthma medication)

4. >2 asthma episodes during the past year that required systemic corticosteroids

6. The child is a patient in Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH

1. Participant is an employee of LCH system

2. Works at or supports the operations of Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH

3. Able to provide informed consent

Exclusion Criteria

1. The caregiver has a smartphone that is not compatible with the Hailie® app.

2. The patient is prescribed a controller (preventive) or rescue inhaler medication to which the Hailie electronic sensor cannot affix.

3. The caregiver is unable to speak and understand English.

a. With this trial, the intent is to first establish feasibility and broaden to different languages in future.

4. The child has clinically significant, comorbid diagnoses, such as cystic fibrosis, cyanotic heart disease, or bronchopulmonary dysplasia, that could interact with their assessment of asthma-related measures.

5. The family has active Department of Child and Family Services (DCFS) involvement

6. The participant is enrolled in another asthma intervention study at the time of enrollment to this study.

7. Child or sibling living in the same home was previously enrolled in this study.

8. Consent is not obtained from the parent/guardian.

9. Parent/guardian does not pass the test of understanding at study enrollment.

1. Participant departs LCH and is no longer an active employee at the time of assessment

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Kristin Kan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kristin Kan, MD

Role: CONTACT

kkan@luriechildrens.org

3122276110

Olivia Orr

Role: CONTACT

oorr@luriechildrens.org

Other Identifiers

K23HL157615

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-6333

Identifier Type: -

Identifier Source: org_study_id