NCT00005711

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Aug 1990

Longer than P75 for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1990

Completed
9.8 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 10, 2016

Status Verified

May 1, 2016

Enrollment Period

17.9 years

First QC Date

May 25, 2000

Last Update Submit

May 6, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health care utilization

    ED visits; hospitalizations

    Enrollment, 12 months, 24 months

Secondary Outcomes (5)

  • School absenteeism

    Enrollment, 12 months, 24 months

  • Lung function (FEV1 % predicted)

    Enrollment, 6, 12, 18, 24 months

  • Quality of life: Impact on Family

    Enrollment, 6, 12, 18, 24 months

  • Quality of life: functional status

    Enrollment, 6, 12, 18, 24 months

  • Self-management

    Enrollment, 6, 12, 18, 24 months

Study Arms (2)

Usual care

NO INTERVENTION

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.

Asthma self-management education

EXPERIMENTAL

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

Interventions

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.

Asthma self-management education

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Physician diagnosis of asthma; moderate severity (1997 criteria), ie. \>= 2 ED visits or 1 hospitalization in past year or prescribed daily asthma medication.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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).

    RESULT
  • 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).

    RESULT

MeSH Terms

Conditions

AsthmaLung Diseases

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

August 1, 1990

Primary Completion

July 1, 2008

Study Completion

July 1, 2009

Last Updated

May 10, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share