Viewing Study NCT00005711



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005711
Status: COMPLETED
Last Update Posted: 2016-05-10
First Post: 2000-05-25

Brief Title: Intervention for Hispanic Children With Asthma
Sponsor: The University of Texas Health Science Center at San Antonio
Organization: The University of Texas Health Science Center at San Antonio

Study Overview

Official Title: Intervention for Hispanic Children With Asthma
Status: COMPLETED
Status Verified Date: 2016-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To design implement and evaluate an intervention program for Hispanic children with asthma which included both a physician education and a patientfamily education component
Detailed Description: 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
HSC19900128H OTHER University of Texas Health Science Center San Antonio httpsreporternihgovquickSearchR01HL045297
R01HL045297 NIH None None