Enhanced asthma care for children using technology

Technology-Enhanced Asthma Care in Children at Clinic and Home (TEACCCH) Study (Aim 2): A Feasibility Randomized Controlled Trial

This study tests if using a mobile app and extra support can help children aged 4-11 with asthma manage their condition better than just using the app alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 4 Years and up
• Sex: All
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago (Academic / other)
• Locations: 1 site (Chicago, Illinois)
• Trial ID: NCT06820593 on ClinicalTrials.gov

What this trial studies

This clinical trial involves parent-child pairs of children aged 4-11 with persistent or uncontrolled asthma. Participants in the intervention group will receive a mobile health app and digital sensors along with enhanced support from an asthma coordinator for remote patient monitoring. The comparison group will also receive the app and sensors but without the additional support, allowing for the collection of inhaler use data. The study aims to evaluate the feasibility and acceptability of this digital intervention in managing pediatric asthma in an outpatient setting.

Who should consider this trial

Good fit: Ideal candidates are children aged 4-11 with a diagnosis of asthma who are prescribed inhaled corticosteroids.

Not a fit: Patients younger than 4 years old or those without a confirmed asthma diagnosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve asthma management and outcomes for children through enhanced monitoring and support.

How similar studies have performed: Other studies have shown promise in using digital health interventions for chronic disease management, suggesting potential success for this approach.

Eligibility criteria

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

Where this trial is running

Chicago, Illinois

• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Kristin Kan, MD

Conditions Asthma in Children; Chronic Diseases in Children; Digital Health