Factors Influencing Pediatric Asthma (FIPA)

Missouri Breaks Industries Research, Inc.

Status: Completed

Conditions: Asthma in Children

Treatments: Behavioral: Intensive Asthma Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03302962

1U54MD008164-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 324 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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 Exclusion Criteria:

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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324 participants in 2 patient groups

Intensive Asthma Education

Experimental group

Description:

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.

Treatment:

Behavioral: Intensive Asthma Education

Routine Asthma Education Literature

No Intervention group

Description:

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