Factors Influencing Pediatric Asthma (FIPA)

October 4, 2017 updated by: Missouri Breaks Industries Research, Inc.
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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Dakota
      • Eagle Butte, South Dakota, United States, 57625
        • Missouri Breaks Industries Research Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Routine Asthma Education Literature
The remaining 54 cases were randomized to the "control" arm and received written materials related to patient-centered asthma control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chart Review of ED Visits
Time Frame: 3 years
Emergency room visits for pulmonary complaints
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2013

Primary Completion (Actual)

May 25, 2017

Study Completion (Actual)

May 25, 2017

Study Registration Dates

First Submitted

September 29, 2017

First Submitted That Met QC Criteria

October 4, 2017

First Posted (Actual)

October 5, 2017

Study Record Updates

Last Update Posted (Actual)

October 5, 2017

Last Update Submitted That Met QC Criteria

October 4, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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