Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma

This study will be a prospective, randomized (1:1), controlled study assessing clinical
status, quality of life, healthcare costs and parental retention rate of asthma knowledge
for children 5 to 12 years old with asthma, following standardized asthma education versus
standard education with an enhanced reinforcement of education intervention.

Group A (the intervention group) The caregivers of the subjects enrolled in this group will
be administered two survey instruments at enrollment (t0), and again via telephone at 2
weeks (t1), 1 months (t2), and 3 months (t3) after enrollment. This group will also receive
reinforced asthma education via telephone at 2 weeks, 1 month, and 3 months after
enrollment.

Group B (the control group) The caregivers of the subjects enrolled in this group will be
administered two survey instruments at enrollment (t0), and again via telephone at 2 weeks
(t1), 1 month (t2), and 3 months (t3) after enrollment. This group will not receive
reinforcing of the asthma education at 2 weeks, 1 month, and 3 months after enrollment.

The two survey instruments administered to the caregivers (parents/legal guardians) of the
subjects enrolled in this study consist of:

1. A validated 16-item questionnaire with multiple-choice answers, assessing asthma
knowledge, trigger identification and avoidance, referred to as "the Asthma Knowledge
Quiz" from here on.

2. A validated 5-item questionnaire with multiple-choice answers, assessing the patient's
quality of life and asthma control, referred to as "the Quality of Life/Asthma Control
Test (QOL/ACT) survey" from here on.

Following enrollment and randomization, the caregiver of each subject will be administered
the two survey instruments prior to discharge from the hospital.

At the end of the administration of the phone surveys (i.e. at 2 weeks, 1 month and 3 months
following enrollment), the study coordinator will provide reinforced asthma education to the
caregiver via telephone for the subjects enrolled in Group A (the intervention group). The
reinforced asthma education will be consistent with the asthma education training session
delivered by the AE before the beginning of the study.

The survey instruments will be administered to the caregiver by the study coordinator in
paper form; after completion by the caregiver, the form will be saved in the subject's
research binder for further data analysis. The PI or the study coordinator will determine
the score for each item on the surveys, and record the scores in the subject's file, in the
Asthma Knowledge Quiz Scores/Asthma Knowledge Retention Rates Form, and the Quality of
Life/Asthma Control Test (QOL/ACT) Scores Form respectively.

The caregiver of each subject will be administered these two survey instruments again, via
telephone, by the study coordinator, at 2 weeks, 1 month, and 3 months after enrollment.
Each item and the multiple-choice answers will be literally read to the parent over the
phone, and the study coordinator will record the answers to each item on the paper survey
forms, which will be saved in the subject's binder for further data analysis. The PI or the
study coordinator will determine the score for each survey, and record the scores in the
subject's file.

A variety of statistical techniques will be used to analyze the data. The investigators will
perform descriptive analyses as well as more analytic work using analysis of variance,
correlation and multiple regression analysis. The investigators will use the expertise of a
biostatistician to assist with accurate analysis of our data. The study will be powered to
detect a significant difference in outcomes between the intervention group (group A) and the
control group (group B); 25 % reduction in cost an 25% improvement in quality of life
scores, following reinforced asthma education, with a 95% CI (alpha=0.05, beta=0.2, for a
power of 80%). The investigators will also analyze whether there is a statistically
significant correlation between the amplitude of the asthma knowledge scores (AKS) and the
asthma knowledge retention rates (AKRR) on one side and the QOL/ACT scores, functional
status and asthma related healthcare costs on the other side.

Inclusion Criteria:

- Children age 5-12 years (eligible on or after the 5th birthday, until the day before
the 13th birthday);

- Hospitalized at Norton Children's Hospital (KCH) for asthma;

- Physician diagnosis of asthma (ICD-9 codes 493.00, 493.01, 493.02, 493.10, 493.11,
493.12, 493.90, 493.91, 493.92);

- Completion of asthma education (standard of care);

- Ability of parent/legal guardian to give informed consent/research authorization, as
evidenced by signing the Informed Consent Form (ICF) approved by the University of
Louisville (UofL) IRB;

- Ability of subject to give informed assent for subjects equal to or older than 7
years of age, as evidenced by signing the Informed Assent Form (IAF) approved by UofL
IRB.

Exclusion Criteria:

- Previous enrollment in either group of this study.