Children With Asthma in New Orleans After Hurricane Katrina

This document presents the protocol for conducting the Head-off Environmental Asthma in
Louisiana (HEAL) study in New Orleans, Louisiana. The goal of the HEAL study is to implement
and test an Asthma Counselor (AC) intervention program that addresses the multidimensional
impact of hurricane Katrina on children with asthma in New Orleans. HEAL is a prospective,
controlled trial in which children will be randomly assigned to one of two treatment groups.
Group 1 children will receive an AC intervention focused on case management, adherence to
medications and education on allergen avoidance. The responsibilities of the AC in this study
are enhanced relative to previous initiatives such as the National Cooperative Inner City
Asthma Study (NCICAS) AC intervention to also provide families with education aimed at
reducing mold, allergens, and moisture in their homes, and materials to aid this effort
(dehumidifiers and HEPA air filters). Since 90% of children with asthma in New Orleans are
sensitive to dust allergens, established allergen control measures will be incorporated into
the AC intervention as well. Group 2 children will receive a high quality standard of care
based on the National Asthma Education and Prevention Program (NAEPP)-NIH guidelines. An
abbreviated AC intervention will be provided to children in Group 2 at the conclusion of the
study. Both treatments will be administered over a 12-month period during which the children
in both groups will receive an extensive clinical evaluation (at baseline and 12-months) and
three environmental home evaluations (focused on moisture, mold and other allergens). In
addition to monitoring the effectiveness of the AC at environmental remediation education,
the environmental home evaluations will also allow some characterization of the relationships
between allergens, post-Katrina environmental exposures and asthma morbidity.

In addition to the enhanced AC intervention, a separate school based survey will be
administered to a sample population of children to examine asthma prevalence and assess
living conditions and stress levels that may have been influenced by hurricane Katrina. The
survey population will consist of a sample of the families of Orleans Parish school children
stratified by age, schools and geographic area of the Parish. The results of the survey, in
combination with the results of the AC intervention, will give us an overview of the extent
and severity of the asthma problem in post hurricane Katrina New Orleans.

The HEAL project is a collaborative multi-institutional research project conducted by the
Tulane University School of Public Health and Tropical Medicine and the New Orleans
Department of Health. To support those efforts, Rho, Inc. will provide for coordination of
data and study activities.

- 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.