Factors Influencing Pediatric Asthma

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.

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Key information

Conditions

Asthma in Children Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Missouri Breaks Industries Research Inc.

Eagle Butte, South Dakota, 57625, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

a diagnosis of asthma on at least 2 occasions by more than one provider during the past 2 years.
refills of asthma treatment medications on at least 2 occasions during the past 2 years.
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.

No diagnosis of asthma by any provider during the past 2 years.
No prescriptions of any asthma meds during the past 2 years.
FEV1 on spirometry greater than 80% of predicted value Exclusion Criteria:

Exclusion criteria

Birthweight less than 2500 grams
Neonatal ventilator treatment
Hospitalization at birth greater than 15 days.
Congenital heart anomaly requiring surgery
Diagnosis of cystic fibrosis
Congenital lung, diaphragm, chest wall, or airway anomaly
Diagnosis of pneumonia, pertussis, or tuberculosis within the past year
Congenital muscular disorder

Treatment and study plan

Intensive Asthma Education

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.

Primary outcomes

Chart Review of ED Visits

Time frame: 3 years

Emergency room visits for pulmonary complaints

Sponsors and collaborators

Lead sponsor

Missouri Breaks Industries Research, Inc.

Other

Collaborators

Sanford Research

Registry information

Acronym: FIPA

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Oct 5, 2017
Registry last updated: Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed