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Factors Influencing Pediatric Asthma (FIPA)

Primary Purpose

Asthma in Children

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Intensive Asthma Education

About this trial

This is an interventional health services research trial for Asthma in Children focused on measuring asthma, pediatric, american indian, children

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept 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:

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

Sites / Locations

Missouri Breaks Industries Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intensive Asthma Education

Routine Asthma Education Literature

Arm 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.

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

Outcomes

Primary Outcome Measures

Chart Review of ED Visits

Emergency room visits for pulmonary complaints

Secondary Outcome Measures

Full Information

NCT ID

NCT03302962

First Posted

September 29, 2017

Last Updated

October 4, 2017

Sponsor

Missouri Breaks Industries Research, Inc.

Collaborators

Sanford Research

1. Study Identification

Unique Protocol Identification Number

NCT03302962

Brief Title

Factors Influencing Pediatric Asthma

Acronym

FIPA

Official Title

Factors Influencing Pediatric Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

March 14, 2013 (Actual)

Primary Completion Date

May 25, 2017 (Actual)

Study Completion Date

May 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Missouri Breaks Industries Research, Inc.

Collaborators

Sanford Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma in Children

Keywords

asthma, pediatric, american indian, children

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

324 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensive Asthma Education

Arm Type

Experimental

Arm Description

Arm Title

Routine Asthma Education Literature

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Intensive Asthma Education

Intervention Description

Primary Outcome Measure Information:

Title

Chart Review of ED Visits

Description

Emergency room visits for pulmonary complaints

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Missouri Breaks Industries Research Inc.

City

Eagle Butte

State/Province

South Dakota

ZIP/Postal Code

57625

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

This study was conducted by permission of the Cheyenne River Sioux Tribe and data sharing is allowed only with their permission. Any investigators wishing to access data from the study should contact Missouri Breaks Industries Research Inc for information on application procedures.

Learn more about this trial

Factors Influencing Pediatric Asthma

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