AsthmaNCT00589719
Asthma in the Delta Region of Arkansas (ADRA): Prevalence and Morbidity
An observational study of Asthma, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of the study is to conduct a cross-sectional study to examine asthma prevalence and morbidity in a predominately minority, low-income population in rural Arkansas. Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 964 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2008
- Phase
- Observational
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: During the 2005-2006 school year, primary caregivers of all students aged 4-17 years attending public school in Eudora and Marvell Arkansas were asked to complete an asthma screening survey regarding their child. The schools are located in two non-contiguous counties in the Delta region of Arkansas and are in rural low-income areas of the state where more than one-third of families with children 5-17 years old meet the 2000 poverty line (Census bureau).
Who may be able to join
- Children aged 4-17 years, enrolled in the public schools in Eudora and Marvell Arkansas.
Who cannot join
- Children aged 18 or older enrolled in the public schools in Eudora and Marvell Arkansas were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
About this study
The purpose of the study is to conduct a cross-sectional study to examine asthma prevalence and morbidity in a predominately minority, low-income population in rural Arkansas.
Read the detailed description
Asthma is the leading chronic disease of childhood in the United States and an important public health concern in Arkansas. Arkansas, a predominately rural state, has one of the leading mortality rates in the nation for African Americans. The specific aims of the study will examine asthma prevalence in children age 4-17 years old in public schools in Eudora and Marvell Arkansas. The study will also examine asthma morbidity among identified asthmatics by characterizing activity limitation, days missed from school, daytime and nocturnal symptoms, healthcare utilization and medication use. The specific aims of the current study will provide novel data on an understudied population of asthmatics and will test our working hypotheses that pediatric asthma prevalence in the Delta region of Arkansas is higher than national estimates; and asthma diagnosis is related to significant morbidity among rural asthmatics.
- Conditions
- Asthma
- Keywords
- Asthma; minority; low-income; African American; Arkansas
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2000,3000,4000 | Children at risk for asthma were identified using a cross-sectional asthma screening survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The findings suggest that asthma diagnosis and active symptoms are prevalent among this predominately minority and low-income rural population in the Arkansas region of the Mississippi Delta.
Measured: One year
Secondary outcomes (1)
High rates of inadequately controlled asthma are evidenced by activity limitation, medication use and increased healthcare utilization.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startAug 2005
- Primary completionMay 2006
- Study completionAug 2008
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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 964 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Tamara T. Perry, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589719
- Sponsor's protocol ID
- 39931
- Status last verified
- Aug 2008
- First submitted
- 27 Dec 2007
- Last updated
- 26 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Galant SP, Crawford LJ, Morphew T, Jones CA, Bassin S. Predictive value of a cross-cultural asthma case-detection tool in an elementary school population. Pediatrics. 2004 Sep;114(3):e307-16. doi: 10.1542/peds.2003-0575-F.
PubMed 15342891
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma in the Delta Region of Arkansas (ADRA): Prevalence and Morbidity
- ClinicalTrials.gov ID
- NCT00589719
- Acronym / sponsor ID
- 39931
- Conditions
- Asthma
- Keywords
- Asthma; minority; low-income; African American; Arkansas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 964 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- May 2006 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 10 Jan 2008 (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.
The purpose of the study is to conduct a cross-sectional study to examine asthma prevalence and morbidity in a predominately minority, low-income population in rural Arkansas.
Detailed description
Asthma is the leading chronic disease of childhood in the United States and an important public health concern in Arkansas. Arkansas, a predominately rural state, has one of the leading mortality rates in the nation for African Americans. The specific aims of the study will examine asthma prevalence in children age 4-17 years old in public schools in Eudora and Marvell Arkansas. The study will also examine asthma morbidity among identified asthmatics by characterizing activity limitation, days missed from school, daytime and nocturnal symptoms, healthcare utilization and medication use. The specific aims of the current study will provide novel data on an understudied population of asthmatics and will test our working hypotheses that pediatric asthma prevalence in the Delta region of Arkansas is higher than national estimates; and asthma diagnosis is related to significant morbidity among rural asthmatics.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2000,3000,4000 | – | –Children at risk for asthma were identified using a cross-sectional asthma screening survey. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- During the 2005-2006 school year, primary caregivers of all students aged 4-17 years attending public school in Eudora and Marvell Arkansas were asked to complete an asthma screening survey regarding their child. The schools are located in two non-contiguous counties in the Delta region of Arkansas and are in rural low-income areas of the state where more than one-third of families with children 5-17 years old meet the 2000 poverty line (Census bureau).
Key inclusion criteria (1 listed)
- Children aged 4-17 years, enrolled in the public schools in Eudora and Marvell Arkansas.
Key exclusion criteria (1 listed)
- Children aged 18 or older enrolled in the public schools in Eudora and Marvell Arkansas were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The findings suggest that asthma diagnosis and active symptoms are prevalent among this predominately minority and low-income rural population in the Arkansas region of the Mississippi Delta.
Time frame: One year
1 secondary outcome
High rates of inadequately controlled asthma are evidenced by activity limitation, medication use and increased healthcare utilization.
Time frame: One 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 26 Aug 2008.
- Results publication: PubMed 15342891Galant SP, Crawford LJ, Morphew T, Jones CA, Bassin S. Predictive value of a cross-cultural asthma case-detection tool in an elementary school population. Pediatrics. 2004 Sep;114(3):e307-16. doi: 10.1542/peds.2003-0575-F.
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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.
Tamara T. Perry, M.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Arkansas Children's Hospital Research Institute 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 1 inclusion and 1 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 26 Aug 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.
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?
The findings suggest that asthma diagnosis and active symptoms are prevalent among this predominately minority and low-income rural population in the Arkansas region of the Mississippi Delta. (time frame: One 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 NCT00589719, 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 26 Aug 2008.