Asthma Clinical Trial
Official title:
Intervention for Hispanic Children With Asthma
To design, implement, and evaluate an intervention program for Hispanic children with asthma which included both a physician education and a patient/family education component.
BACKGROUND:
Although asthma affects 6-10 percent of children aged 6-16 years, the prevalence of asthma
in Hispanic groups and the degree of resulting morbidity were unknown in 1990. The study
sought to answer the following questions: 1) Would a physician education intervention result
in improved medical management for Hispanic children with asthma who were cared for within
the context of an outpatient clinic? 2) Would a focused educational intervention for
Hispanic children with asthma and their families result in decreased morbidity and improved
quality of life? If effective, the physician education and patient education programs could
serve as models for the implementation of similar programs in outpatient clinic settings
which serve Hispanic children with asthma.
The study was part of a demonstration and education initiative "Interventions for Control of
Asthma Among Black and Hispanic Children" which was released by the NHLBI in June 1989.
DESIGN NARRATIVE:
Prior to enrollment of patients, all physicians participated in an intervention which
included the following elements: a brief seminar about medical management for children with
asthma, introduction of protocols in low chart format (algorithms), use of a standardized
progress note from for children with asthma, a series of computer-based simulations and
individualized feedback to physicians. The effectiveness of the physician education
component in changing physician behavior was measured by pre- /post-test, chart audit, and
performance on computer-based simulations.
One hundred sixty (160) Hispanic children with asthma, aged 6-15 years who were cared for in
a pediatric residents' continuity clinic were enrolled for study. A research associate
interviewed parents and children separately using standardized questionnaires to obtain
information about 1) health beliefs, 2) reported health behavior, 3) knowledge and attitudes
about asthma, 4) functional morbidity, 5) acculturation, and 6) socio-demographic factors. A
research nurse performed spirometry on each subject. Additional information was obtained by
review of medical records and school attendance records. Patients were then randomized into
treatment and control groups. Treatment group patients and their families participated in
the patient education intervention. The intervention consisted of a series of four
videotapes and written materials which focused on major aspects of self-management for
children with asthma. Patients and families received the four modules at one month
intervals. Selected modules were reviewed with the research nurse at appointed visits
approximately six, 9, and 12 months following enrollment. Follow-up data were obtained by
interview, medical record review, and spirometry at six, 12, 18, and 24 months following
enrollment.
Intervention and control group children were compared for morbidity (the number of emergency
room visits, hospitalizations, school days missed) and quality of life (impact on family and
functional status), after controlling for confounding variables. Secondary data analysis
examined the effect of the intervention on knowledge, reported health behaviors, and
post-intervention spirometry.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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