- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03302962
Factors Influencing Pediatric Asthma (FIPA)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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South Dakota
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Eagle Butte, South Dakota, United States, 57625
- Missouri Breaks Industries Research Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1U54MD008164-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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