Expired Study
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Baltimore, Maryland 21287


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

HBV 99-01-11-01


NCT ID:

NCT00218803


Secondary ID:

5R01NR005062-04


Study Acronym:


Brief Title:

Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their Asthma


Official Title:

A+ Asthma Rural Partnership


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

5 Years


Maximum Age:

12 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Nursing Research (NINR)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Sing


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

220


Enrollment Type:

Actual


Overall Contact Information

Official Name:Arlene M Butz, SCD,MSN,BSN
Principal Investigator
Johns Hopkins University

Study Dates

Start Date:August 2000
Completion Date:March 2005
Completion Type:Actual
Primary Completion Date:March 2005
Primary Completion Type:Actual
Verification Date:September 2008
Last Changed Date:September 3, 2008
First Received Date:September 20, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Asthma Education
Time Frame:10 months or 1 school year
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Decrease in emergency department visits
Time Frame:10 months or 1 school year
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Nurse asthma education intervention
Description:Asthma Education
Arm Name:1
Intervention Type:Behavioral
Name:Control Group
Description:Asthma Education
Arm Name:2

Study Arms

Study Arm Type:Other
Arm Name:2
Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Nursing Research (NINR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Naumann PL, Huss K, Calabrese B, Smith T, Quartey R, Van de Castle B, Lewis C, Hill K, Walker J, Winkelstein M. A+ Asthma Rural Partnership coloring for health: an innovative rural asthma teaching strategy. Pediatr Nurs. 2004 Nov-Dec;30(6):490-4.
PMID:15704600

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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