AsthmaPhase 3NCT00218803
Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their Asthma
A Phase 3 study testing Nurse asthma education intervention in people with Asthma, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Nurse asthma education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Nurse asthma education intervention, Control Group
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse asthma education interventionBehavioural
Asthma Education
Control GroupBehavioural
Asthma Education
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Nurse asthma education intervention |
| 2 | Other | Not described Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in emergency department visits
Measured: 10 months or 1 school year
Secondary outcomes (1)
Asthma Education
Measured: 10 months or 1 school year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2000
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Arlene M Butz, SCD,MSN,BSN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218803
- Sponsor's protocol ID
- HBV 99-01-11-01
- Other IDs
- 5R01NR005062-04
- Status last verified
- Sep 2008
- First submitted
- 20 Sep 2005
- Last updated
- 5 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15704600
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A+ Asthma Rural Partnership
- ClinicalTrials.gov ID
- NCT00218803
- Acronym / sponsor ID
- HBV 99-01-11-01
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Aug 2000
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Nurse asthma education intervention |
| 2 | Other | Behavioral: Control Group |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse asthma education interventionAsthma Education | Behavioural | 1 |
| Control GroupAsthma Education | Behavioural | 2 |
Primary outcome
Decrease in emergency department visits
Time frame: 10 months or 1 school year
1 secondary outcome
Asthma Education
Time frame: 10 months or 1 school year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
- Background: PubMed 15704600Naumann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene M Butz, SCD,MSN,BSN principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nurse asthma education intervention in people with Asthma, run by National Institute of Nursing Research (NINR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in emergency department visits (time frame: 10 months or 1 school year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218803, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2008.