An interventional study of Asthma self-management education in Asthma and Lung Diseases, sponsored by The University of Texas Health Science Center at San Antonio. Completed. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2016-05-10.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 145 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Physician diagnosis of asthma; moderate severity (1997 criteria), ie. >= 2 ED visits or 1 hospitalization in past year or prescribed daily asthma medication.
Control group children received routine medical care by their primary care providers as well as study visits every 6 months. At each study visit, following assessment of technique for using peak flow and metered dose inhalers, errors were corrected and children/families were coached on correct technique.
Treatment group children and their families participated in the patient education program which consisted of four separate one-hour sessions. The topics were: symptoms of asthma, causes of asthma ("triggers"), medications, and peak flow. A bilingual nurse educator working one-on-one with the child and family members delivered these four sessions. The four sessions were delivered over a six week period. Culturally sensitive educational materials include both print (flip charts, take-home brochures) and videotape materials. The videotapes feature children from the clinic and highlight how they successfully manage their asthma. All materials are available in both English and Spanish.
Behavioral: Asthma self-management education
Treatment group children and their families participated in the patient education program which consisted of four separate one-hour sessions. The topics were: symptoms of asthma, causes of asthma ("triggers"), medications, and peak flow. A bilingual nurse educator working one-on-one with the child and family members delivered these four sessions. The four sessions were delivered over a six week period. Culturally sensitive educational materials include both print (flip charts, take-home brochures) and videotape materials. The videotapes feature children from the clinic and highlight how they successfully manage their asthma. All materials are available in both English and Spanish.
Health care utilization
ED visits; hospitalizations
Time frame: Enrollment, 12 months, 24 months
School absenteeism
Number of school days misses per year
Time frame: Enrollment, 12 months, 24 months
Lung function (FEV1 % predicted)
FEV1 % predicted
Time frame: Enrollment, 6, 12, 18, 24 months
Quality of life: Impact on Family
Impact on Family scores
Time frame: Enrollment, 6, 12, 18, 24 months
Quality of life: functional status
functional impairment (FSII scores)
Time frame: Enrollment, 6, 12, 18, 24 months
Self-management
self-reported self-management behaviors
Time frame: Enrollment, 6, 12, 18, 24 months
No study locations are listed for this record.
Plan to share: No
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The University of Texas Health Science Center at San Antonio