To Determine the Measurement Properties of the ACT in an African American Adolescent Population With Persistent Asthma

African Americans have a higher rate of asthma (11.2%) compared to whites (7.7%), according
to the Centers for Disease Control and Prevention, and this asthma is disproportionally not
well-controlled. African Americans have higher mortality from and healthcare utilization for
their asthma. Their asthma severity is more likely to be underestimated by their "main asthma
provider". African-American adolescents are at particularly high risk of asthma-related
morbidity and mortality.

Because asthma control is now the focus of asthma care, assessment of control is the critical
step in appropriate management. The two domains of asthma control, impairment and risk,
evaluate the role asthma plays in a patient's quality of life and functional capacity on an
ongoing basis and the risk their asthma presents for future adverse events. Although NAEPP
guidelines contain a rubric for asthma control based on these domains, thus representing the
"gold standard" for asthma care, their utilization may be time-consuming and cumbersome to
implement in primary care offices, and primary care providers may be unfamiliar with their
use. Minorities see subspecialists less often than Caucasians (28.3% vs 41%, p=0.001), and
this difference could not be explained by age, gender, health insurance, education,
employment, patient preference, or frequency of respiratory symptoms. For primary care
practices following these patients, it remains imperative that the tools being used to gauge
asthma control be evaluated and validated in this at-risk population.

At this time, there are approximately 17 questionnaires available for use in the assessment
of asthma control, although most are not well validated. Of these, the most widely validated
and most commonly used instrument is the Asthma Control Test (ACT). The ACT is a
self-administered questionnaire intended to assess the impairment domain over the past four
weeks and is completed by patients starting at age 12. The ACT has five questions with an
overall best score of 25. For primarily adult Caucasian populations, the ACT has been found
to be a valid, reliable, and responsive instrument of asthma control, and cut-offs for
controlled and not well-controlled asthma (< 19) as well as minimal clinically important
(MIC) differences (3 points) have been identified. However, measurement properties of the ACT
are lacking in the African American adolescent asthma population. The landmark validation
study for the ACT by Schatz et al was comprised of a large sample size of over 300 patients
that showed that a cut-off score of 19 as distinguishing well-controlled versus not
well-controlled asthmatics. However, the mean age was 35 for that study population, and
concerns have been raised as to whether this cut-off is appropriate for adolescents in
general. Moreover, concerns have been raised as to the application of these cut-offs for
different ethnic populations. Recent studies examining the ACT in pediatric adolescent
populations have found higher optimal cut points to distinguish control classifications;
these groups included both European cohorts as well as children of Mexican descent in
Southern California. The ACT has not been validated in a more ethnically diverse population
such as in African American adolescents.

The measurement properties of validity, reliability, and responsiveness are critical to the
usefulness of any questionnaire in both clinical and research settings. To date, we have been
unable to identify a study that evaluated the measurement properties of the ACT in this
at-risk minority population.

Lung function measures are included in the rubric of assessing asthma control by the NAEPP.
Per these recommendations, spirometry should be available to physicians caring for asthma
patients and used with initiation of treatment, change in asthma control, and every one to
two years. While subspecialists often have access to spirometry, office-based spirometry is
time-consuming, requires technical ability and staff training, equipment maintenance and
calibration, and is not always available or feasible for use in primary care physician
offices. Because spirometry may be of limited accessibility to primary care providers,
questionnaires are quickly taking a leading role in asthma management. However, African
Americans perceive asthma symptoms differently than Caucasians. They report less nighttime
awakening and dyspnea, two symptoms that account for 20% of the ACT score, and children are
less accurate describing their perceived asthma control. This type of under-reporting
reflects a false level of asthma control when queried by the ACT and leads to inappropriate
medical management when spirometry is not utilized.

Additionally, health literacy is often underestimated. In a review by Diette of approximately
500 mostly African American patients who were asked to read asthma information, only 27% were
able to read at a high school level, the level at which most health information and
instructions are written. Patients with limited health literacy and chronic illness know less
about how to manage their disease and have a higher likelihood of poorly controlled disease
and health status compared to their counterparts with higher health literacy. Due to this,
the IOM identifies health literacy as being fundamental to quality care and also considers it
a priority in health-care quality and disease prevention. Because currently used
questionnaires are often provided to patients at the time of intake at a clinic visit for
self-administration, a high level of health literacy in this minority adolescent population
is a dangerous assumption that must be considered when addressing the utilization of tools in
the assessment of asthma control by primary care providers and subspecialists alike.

As exploratory endpoints, we will obtain fractional exhaled nitric oxide (FeNO) measurements
shortly after spirometry is performed. Elevated FeNO indicates eosinophilic airway
inflammation and assists in assigning the correct asthma phenotype, which can have
implications for asthma management. We will also obtain nasal epithelial lining fluid (ELF)
for collection of nasal cytokines and chemokines. This information is useful for expanding
our current understanding of the inflammatory mediators involved in asthma-associated airway
inflammation.

Inclusion Criteria:

- Self-identified as African-American

- Ages 12-18 years

- Live within convenient driving distance of the NC Children's Specialty Clinic in
Raleigh, NC.

- Physician-diagnosis of persistent asthma

- Current treatment with appropriate therapy for persistent asthma symptoms as per the
NHLBI guidelines including: Daily controller medication use for asthma requiring at
least low-dose inhaled corticosteroids (ICS). Asthma may range from mild persistent
through severe persistent asthma, to include subjects that may require daily or every
other day oral corticosteroids for control of asthma symptoms

Exclusion Criteria:

- Children younger than age 12 and older than 18

- Children unable to perform spirometry

- Medical history or underlying health problems that may preclude participation in the
protocol per the study physician (including but not limited to cystic fibrosis,
chronic bronchitis, recurrent pneumonia, immunodeficiency, hematologic disorders)

- Subjects and families unwilling to travel to the clinic for the required 2 visits

- Other uncontrolled health problems

- Non-English speaking subjects