Factors Influencing Pediatric Asthma

NCT03302962 | Completed DMC

• 1 other identifier: 1U54MD008164-01
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

asthma; pediatric; american indian; children

Outcome Measures

Primary Outcomes (1)

• Chart Review of ED Visits

  Emergency room visits for pulmonary complaints

  3 years

Study Arms (2)

Intensive Asthma Education

EXPERIMENTAL

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.

Behavioral: Intensive Asthma Education

Routine Asthma Education Literature

NO INTERVENTION

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

Interventions

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.

Intensive Asthma Education

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Missouri Breaks Industries Research, Inc.: lead
• Sanford Research: collaborator

Study Sites (1)

Missouri Breaks Industries Research Inc.

Eagle Butte, South Dakota, 57625, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 5, 2017
• Study Start: March 14, 2013
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)