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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT00426634
Eligibility Criteria:
* INCLUSION CRITERIA:
A child will be included in the HEAL intervention study if he or she:
1. Is a male or female child four to twelve years old, inclusive, at the time of recruitment, living in Orleans Parish or surrounding areas impacted by flooding.
2. Has previously been given a diagnosis of asthma by a healthcare provider and who has symptoms as described below (Criteria 3) for more than one year.
3. Is currently receiving long-term asthma control therapy, as reported at baseline, and either has symptoms consistent with persistent asthma (criterion 3a, see below) or has evidence of uncontrolled disease (criterion 3b); or is not currently receiving long-term asthma control therapy and has symptoms consistent with persistent asthma (criterion 3a) and also has evidence of uncontrolled disease (criterion 3b):
3a. Evidence of persistent asthma as defined by the National Asthma Education and Prevention Program (NAEPP) of the National Heart Lung and Blood Institute Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma (1997), which includes: asthma symptoms 3 or more days per week during the last two weeks, sleep disturbed due to asthma at least 3 times in the past month, or albuterol use (Metered Dose Inhaler or nebulizer) for quick relief at least 8 times in the past two weeks, not including use as a preventive for exercise.
3b. Evidence of uncontrolled disease as defined by at least one of the following additional criteria:
i. One asthma-related unscheduled visit to an emergency department (ED), urgent care (UC), or clinic in the previous 12 months.
ii. One asthma-related overnight hospitalization in the previous 12 months.
iii. One or more bursts of oral corticosteroids or equivalent in the previous 12 months.
4\) Has a parent or legal guardian willing to sign the written informed consent prior to initiation into the study.
5\) Is willing to sign the assent form, if age appropriate.
EXCLUSION CRITERIA:
A child will be excluded from the HEAL intervention study if she or he:
1. Is defined as having mild intermittent asthma at baseline evaluation.
2. Has had a life-threatening asthma exacerbation in the last 5 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure.
3. Has significant medical illnesses other than asthma such as: any hematologic, endocrine, respiratory (other than asthma) or cardiac condition requiring daily medications; significant neurological disorder requiring daily medications; any clotting disorder; any obvious severe mental retardation that prohibits the child or the child s caregiver from answering questions or following instructions; any autoimmune disease; any immune deficiency; or any other serious medical condition including Juvenile diabetes mellitus, hypo- or hyper- thyroidism, hemophilia, Von Willebrands disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis.
4. Has not had a home evaluation completed within 4-6 weeks of the Screening Visit (may be re-screened).
5. Lives with a foster parent.
6. Has caregiver (typically the parent or guardian) who does not have access to a phone.
7. Plans to move out of the recruitment area over the next year.
One child from each household will be selected to participate in the study. In the case of multiple eligible children, the youngest child will be included in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT00426634
Study Brief:
Protocol Section:
NCT00426634