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:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-24 @ 3:25 PM
NCT ID:
NCT04995692
Eligibility Criteria:
Inclusion Criteria (all 4 criteria must be met):
1. Physician diagnosis of asthma, based on review of medical records.
2. Inpatient admission to GCH with asthma as a primary or secondary diagnosis.
3. Persistent asthma or poor asthma control for which a daily controller medication is recommended by NHLBI guidelines, defined as any 1 of the following:
1. \>2 days per week with asthma symptoms in the past month;
2. \>2 days per week with rescue medication use in the past month;
3. \>2 days per month with nighttime symptoms in the past month; or
4. ≥1 other episode(s) of asthma during the past year that required systemic corticosteroids
4. Age between ≥5 and ≤11 years.
Exclusion Criteria:
1. An inability to speak and understand English. Parents and children with low literacy / health-literacy skills will be eligible, as survey instruments will be administered verbally and educational materials will be designed for low-literacy populations.
2. No access to a working phone for follow-up survey assessments.
3. No access to a smartphone (or other 'smart' device) for telehealth education.
4. Another significant medical condition, including Cystic Fibrosis, congenital heart disease, or other chronic lung disease, that could interfere with assessment of asthma-related measures.
5. A diagnosed developmental condition (e.g. Autism spectrum disorder or significant developmental delay) identified in the child's medical record that could interfere with a child's ability to participate in teaching activities, and/or potentially delay the transition of responsibility for inhaled asthma medications from caregiver to child.
6. If the child or family is currently enrolled in a study conducted by The Preventive Care Program for Urban Children with Asthma (led by Dr. Jill Halterman).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
13 Years
Study:
NCT04995692
Study Brief:
Protocol Section:
NCT04995692