Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06820593
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT06820593
Study Brief:
Protocol Section:
NCT06820593