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Factors Influencing Pediatric Asthma

NCT ID: NCT03302962

Last Updated: 2017-10-05

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-14

Study Completion Date

2017-05-25

Brief Summary

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Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple physiologic, environmental and social conditions impact the prevalence and severity of asthma. Even when diagnosed, effective control can be impeded by improper use of medication, not understanding or being unable to avoid environmental triggers, lack of continuity in follow-up care, and lack of an asthma action plan. American Indians are especially at-risk for health problems related to asthma. American Indians have the highest asthma rate among single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are diagnosed with asthma in the general population but little is known about why this is true. Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial influences on disease and this study investigated the possible improvement in asthma control from an intensive educational intervention.

Detailed Description

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The primary aim of this study was to test the hypothesis that intensive patient education regarding self-directed, stepped care will result in reduced morbidity and medical care utilization, while increasing quality of life.

One half (54) of the identified cases will be randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.

Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intensive Asthma Education

One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.

Group Type EXPERIMENTAL

Intensive Asthma Education

Intervention Type BEHAVIORAL

One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.

Routine Asthma Education Literature

The remaining 54 cases were randomized to the "control" arm and received written materials related to patient-centered asthma control.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive Asthma Education

One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Cases must be "American Indian" (eligibile for care within the Indian Health Service); and at least 2 of the following 3 criteria:

1. a diagnosis of asthma on at least 2 occasions by more than one provider during the past 2 years.
2. refills of asthma treatment medications on at least 2 occasions during the past 2 years.
3. Improvement of spirometry FEV1 of 20% with use of albuterol MDI or nebulizer.
* Controls meet the same demographic criteria as cases, but must also meet all of the following criteria.

1. No diagnosis of asthma by any provider during the past 2 years.
2. No prescriptions of any asthma meds during the past 2 years.

Exclusion Criteria

1. Birthweight less than 2500 grams
2. Neonatal ventilator treatment
3. Hospitalization at birth greater than 15 days.
4. Congenital heart anomaly requiring surgery
5. Diagnosis of cystic fibrosis
6. Congenital lung, diaphragm, chest wall, or airway anomaly
7. Diagnosis of pneumonia, pertussis, or tuberculosis within the past year
8. Congenital muscular disorder
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanford Research

OTHER

Sponsor Role collaborator

Missouri Breaks Industries Research, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Missouri Breaks Industries Research Inc.

Eagle Butte, South Dakota, United States

Site Status

Countries

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United States

Other Identifiers

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1U54MD008164-01

Identifier Type: NIH

Identifier Source: org_study_id

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