Recruiting

Asthma with RPM

Sponsor:

Ann & Robert H Lurie Children's Hospital of Chicago

Code:

NCT06820593

Conditions

Asthma in Children

Chronic Diseases in Children

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

Interventions

Digital Asthma Intervention

Comparison Group

Study Details

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 ID

NCT06820593

Start date

Mar 14, 2025

Status verified date

Sep, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4+

Healthy Volunteers: Accepted

Inclusion into the study will not depend on sex, ethnicity, or race. We will monitor enrollment to ensure a diversity of sex and race/ethnicity are represented.

PARENT-CHILD PAIR 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

PARENT-CHILD PAIR 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.

HEALTH CARE PROVIDER INCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)

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

HEALTH CARE PROVIDER EXCLUSION CRITERIA (IMPLEMENTATION OUTCOMES)

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

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.

Primary outcome measure

  • Study Feasibility [ Time Frame: Baseline, 12 months ]

Central Contacts and Locations

Central contacts

Locations

Ann & Robert H Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

More Information

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Last update posted

Sep 10, 2025

Last verified

Sep, 2025

Keywords

  • Digital Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ann & Robert H Lurie Children's Hospital of Chicago on 2025-09-10.