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Factors Influencing Pediatric Asthma

Factors Influencing Pediatric Asthma

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03302962
Acronym
FIPA
Enrollment
324
Registered
2017-10-05
Start date
2013-03-14
Completion date
2017-05-25
Last updated
2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children

Keywords

asthma, pediatric, american indian, children

Brief summary

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

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.

Interventions

BEHAVIORALIntensive 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.

Sponsors

Sanford Research
CollaboratorOTHER
Missouri Breaks Industries Research, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No

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. 3. FEV1 on spirometry greater than 80% of predicted value

Design outcomes

Primary

MeasureTime frameDescription
Chart Review of ED Visits3 yearsEmergency room visits for pulmonary complaints

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026