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Intervention for Hispanic Children With Asthma

Primary Purpose

Asthma, Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Asthma self-management education
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

6 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Physician diagnosis of asthma; moderate severity (1997 criteria), ie. >= 2 ED visits or 1 hospitalization in past year or prescribed daily asthma medication.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Usual care

    Asthma self-management education

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Health care utilization
    ED visits; hospitalizations

    Secondary Outcome Measures

    School absenteeism
    Number of school days misses per year
    Lung function (FEV1 % predicted)
    FEV1 % predicted
    Quality of life: Impact on Family
    Impact on Family scores
    Quality of life: functional status
    functional impairment (FSII scores)
    Self-management
    self-reported self-management behaviors

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 6, 2016
    Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005711
    Brief Title
    Intervention for Hispanic Children With Asthma
    Official Title
    Intervention for Hispanic Children With Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1990 (undefined)
    Primary Completion Date
    July 2008 (Actual)
    Study Completion Date
    July 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Health Science Center at San Antonio
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma, Lung Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    145 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    Asthma self-management education
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Asthma self-management education
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Health care utilization
    Description
    ED visits; hospitalizations
    Time Frame
    Enrollment, 12 months, 24 months
    Secondary Outcome Measure Information:
    Title
    School absenteeism
    Description
    Number of school days misses per year
    Time Frame
    Enrollment, 12 months, 24 months
    Title
    Lung function (FEV1 % predicted)
    Description
    FEV1 % predicted
    Time Frame
    Enrollment, 6, 12, 18, 24 months
    Title
    Quality of life: Impact on Family
    Description
    Impact on Family scores
    Time Frame
    Enrollment, 6, 12, 18, 24 months
    Title
    Quality of life: functional status
    Description
    functional impairment (FSII scores)
    Time Frame
    Enrollment, 6, 12, 18, 24 months
    Title
    Self-management
    Description
    self-reported self-management behaviors
    Time Frame
    Enrollment, 6, 12, 18, 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Physician diagnosis of asthma; moderate severity (1997 criteria), ie. >= 2 ED visits or 1 hospitalization in past year or prescribed daily asthma medication.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    9006232
    Citation
    Hendricson WD, Wood PR, Hidalgo HA, Ramirez AG, Kromer ME, Selva M, Parcel G. Implementation of individualized patient education for Hispanic children with asthma. Patient Educ Couns. 1996 Nov;29(2):155-65. doi: 10.1016/0738-3991(96)00861-0.
    Results Reference
    result
    PubMed Identifier
    8193683
    Citation
    Hendricson WD, Wood PR, Hidalgo HA, Kromer ME, Parcel GS, Ramirez AG. Implementation of a physician education intervention. The Childhood Asthma Project. Arch Pediatr Adolesc Med. 1994 Jun;148(6):595-601. doi: 10.1001/archpedi.1994.02170060049008.
    Results Reference
    result
    PubMed Identifier
    10980046
    Citation
    Kromer ME, Prihoda TJ, Hidalgo HA, Wood PR. Assessing quality of life in Mexican-American children with asthma: impact-on-family and functional status. J Pediatr Psychol. 2000 Sep;25(6):415-26. doi: 10.1093/jpepsy/25.6.415.
    Results Reference
    result
    Citation
    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).
    Results Reference
    result
    Citation
    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).
    Results Reference
    result

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    Intervention for Hispanic Children With Asthma

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