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Intervention for Hispanic Children With Asthma

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00005711
First received: May 25, 2000
Last updated: May 6, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Asthma
Lung Diseases
Behavioral: Asthma self-management education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Intervention for Hispanic Children With Asthma

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Health care utilization [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    ED visits; hospitalizations


Secondary Outcome Measures:
  • School absenteeism [ Time Frame: Enrollment, 12 months, 24 months ] [ Designated as safety issue: No ]
    Number of school days misses per year

  • Lung function (FEV1 % predicted) [ Time Frame: Enrollment, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    FEV1 % predicted

  • Quality of life: Impact on Family [ Time Frame: Enrollment, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    Impact on Family scores

  • Quality of life: functional status [ Time Frame: Enrollment, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    functional impairment (FSII scores)

  • Self-management [ Time Frame: Enrollment, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    self-reported self-management behaviors


Enrollment: 145
Study Start Date: August 1990
Study Completion Date: July 2009
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
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.
Experimental: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
Physician diagnosis of asthma; moderate severity (1997 criteria), ie. >= 2 ED visits or 1 hospitalization in past year or prescribed daily asthma medication.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Hidalgo H, Prihoda T, Arfken C, Evans D, Hanson J, Lapidus J, Malveaux F, Mellins R, Murphy S, Ramos C, Rand C, Strunk R, Sussman L, Thompson L, Wood P. Impact of home smoke exposure on black and hispanic children with asthma: a multi-center study. 1996. p. A420. (Am J Respir Crit Care Med; vol. 153).
Wood PR, Hidalgo HA, Prihoda TJ, Kromer ME, Hendricson WD, Ramirez AG, Marinez YM. Asthma in hispanic children: a controlled study of the impact of patient education on morbidity. 1996. p. A276. (Am J Respir Crit Care Med; vol. 153).

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00005711     History of Changes
Other Study ID Numbers: 4920  R01HL045297  HSC19900128H 
Study First Received: May 25, 2000
Last Updated: May 6, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on December 08, 2016