Intervention for Hispanic Children With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

1990-08-31

Study Completion Date

2009-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Community Intervention for Minority Children With Asthma

NCT00005715

Asthma Lung Diseases

COMPLETED

Interventions to Improve Asthma Management/Prevention at School

NCT00005736

Asthma Lung Diseases

COMPLETED

Self Management Education Asthma

NCT00005712

Asthma Lung Diseases

TERMINATED

Asthma Partnership for Minority Children

NCT00005716

Asthma Lung Diseases

COMPLETED

A Coping Skills Program for Children With Asthma

NCT05118282

Asthma in Children

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Lung Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Asthma self-management education

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No