- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218803
Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their Asthma
September 3, 2008 updated by: National Institute of Nursing Research (NINR)
A+ Asthma Rural Partnership
To determine if teaching rural children with asthma and their parents about appropriate medication use, asthma triggers unique to a rural setting and increasing access to medical care will result in a decrease in emergency department visits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Many self-management asthma interventions have demonstrated increase in asthma knowledge, reduced emergency department visits, increased self-efficacy and quality of life.
The type of self-management interventions, specifically individualized and interactive educational interventions, have been suggested to have the strongest effect on asthma morbidity.
Few studies have tested asthma self-management educational interventions in increasing knowledge, self-efficacy and quality of life in rural pediatric populations.
The goal of this study was to test the effectiveness of an asthma educational intervention in improving asthma knowledge in rural children and their parent/caregivers.
We hypothesized that an interactive asthma educational intervention would increase parent/caregiver and child asthma knowledge resulting in decreased emergency room visits in rural families of children with asthma.
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Phase 3
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
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins University
-
-
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
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physician diagnosed asthma, attend elementary school in rural county agreeing to participate
Exclusion Criteria: Participation in another asthma study or having other respiratory illness such as cystic fibrosis, BPD
-
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
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Asthma Education
|
Other: 2
|
Asthma Education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease in emergency department visits
Time Frame: 10 months or 1 school year
|
10 months or 1 school year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Asthma Education
Time Frame: 10 months or 1 school year
|
10 months or 1 school year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arlene M Butz, SCD,MSN,BSN, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
August 1, 2000
Primary Completion (Actual)
March 1, 2005
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
September 20, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
September 5, 2008
Last Update Submitted That Met QC Criteria
September 3, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBV 99-01-11-01
- 5R01NR005062-04 (U.S. NIH Grant/Contract)
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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