Factors Influencing Pediatric Asthma

Not Applicable

Completed

• Conditions: Asthma in Children
• Interventions: Behavioral: Intensive Asthma Education

• Registration Number: NCT03302962
• Lead Sponsor: Missouri Breaks Industries Research, Inc.

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.

Study Timeline

• Study Start: 2013-03-14
• Primary Completion: 2017-05-25
• Study Completion: 2017-05-25
• Study First Submitted: 2017-09-29
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-04
• Last Update Submitted: 2017-10-04
• Study First Posted: 2017-10-05
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Asthma Education	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.

Primary Outcome Measures

Name	Time	Method
Chart Review of ED Visits	3 years	Emergency room visits for pulmonary complaints

Trial Locations

Locations (1)

Missouri Breaks Industries Research Inc.; 🇺🇸 Eagle Butte, South Dakota, United States