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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT03390556
Eligibility Criteria:
Inclusion Criteria: (all 5 criteria must be met)
1. Physician diagnosis of asthma, based on review of medical records.
2. Uncontrolled asthma consistent with National Heart, Lung, and Blood Institute (NHLBI) guidelines, with at least 1 of the following based on caregiver report:
a. If the child is 7-11 years old: i. An average of \>2 days per week with asthma symptoms ii. \>2 days per week with rescue medication use iii. \>2 days per month with nighttime symptoms iv. ≥2 episodes of asthma during the past year that have required systemic corticosteroids b. If the child is 12-14 years old: i. An average of \>2 days per week with asthma symptoms ii. \>2 days per week with rescue medication use iii. Nighttime symptoms 1-3 times per week iv. ≥2 episodes of asthma during the past year that have required systemic
3. The child must have a current prescription (within the past year) of an inhaled asthma controller medication, such as an inhaled corticosteroid (ICS), based on review of electronic medical records.
4. The child/adolescent is between ≥7 and ≤14 years old.
5. The child/adolescent is insured by Medicaid or Medicaid managed care program.
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, including care coordinator calls and the final follow-up survey.
3. Another significant medical condition identified in the child's medical record that could interfere with assessment of asthma control, including Cystic Fibrosis, congenital heart disease, or other chronic pulmonary disease.
4. A diagnosed developmental condition (e.g. Autism spectrum disorder or significant developmental delay) identified in the child's medical record that could impact the transition of responsibility for inhaled asthma medications from caregiver to child.
5. 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:
7 Years
Maximum Age:
14 Years
Study:
NCT03390556
Study Brief:
Protocol Section:
NCT03390556