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Factors Influencing Pediatric Asthma (FIPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302962
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
Sanford Research
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma in Children Behavioral: Intensive Asthma Education Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Factors Influencing Pediatric Asthma
Actual Study Start Date : March 14, 2013
Actual Primary Completion Date : May 25, 2017
Actual Study Completion Date : May 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.
Behavioral: 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.

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.



Primary Outcome Measures :
  1. Chart Review of ED Visits [ Time Frame: 3 years ]
    Emergency room visits for pulmonary complaints



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302962


Locations
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United States, South Dakota
Missouri Breaks Industries Research Inc.
Eagle Butte, South Dakota, United States, 57625
Sponsors and Collaborators
Missouri Breaks Industries Research, Inc.
Sanford Research

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Responsible Party: Missouri Breaks Industries Research, Inc.
ClinicalTrials.gov Identifier: NCT03302962     History of Changes
Other Study ID Numbers: 1U54MD008164-01 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Missouri Breaks Industries Research, Inc.:
asthma
pediatric
american indian
children
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases