AsthmaNCT00201071
Asthma Surveillance and Education in Preschool Settings
An observational study of Asthma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness of a bilingual intervention in improving asthma care for low-income inner-city children enrolled in subsidized preschool childcare programs. Read more about this study
- Who is it for?
- Ages 2 to 4 years
- Conditions the study is for
- Asthma
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jan 2011
- 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 2 to 4 years
- All sexes
- No healthy volunteers
- Child
Study population: We formed collaborative agreements with subsidized day care providers in three New York City communities with high asthma prevalence. These three communities - Harlem, the South Bronx and the Lower East Side - are economically disadvantaged communities of color. Participants were parents or guardians of children with asthma enrolled in subsidized day care center. 95% of participants were female, 64% were Hispanic, 25% were Black, 1% were White and 10% were Other. 70% were born in the continental USA, 70% spoke English as their primary language. 30% had earned less than a HS degree, 32% had received a HS diploma or a GED, 37% had attended som college, and 1% had completed college. 33% of participants had family incomes of less than $1,000 per month, 35% had incomes of $1,000 to $1,999 and 32% had incomes over $2,000.
Who may be able to join
- Enrolled in specific subsidized preschools in New York City
- 2.8 to 4 years old
- Persistent asthma as defined by symptom reports
- Use of quick-relief agents or controller medications
Who cannot join
- History of intubation
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Academy of Medicine, CUES
New York, New York, 10029
About this study
The purpose of this study is to test the effectiveness of a bilingual intervention in improving asthma care for low-income inner-city children enrolled in subsidized preschool childcare programs.
Read the detailed description
BACKGROUND:
Proposed is a non-randomized, controlled, prospective trial to test the efficacy of a bilingual intervention to improve asthma care for low-income inner-city children enrolled in subsidized preschool childcare programs. Because of high rates of asthma prevalence, subsidized preschool childcare programs offer ideal settings to test innovative strategies to improve asthma care within communities at highest risk of morbidity.
DESIGN NARRATIVE:
The study will comprise three arms. Arm 1 is surveillance, in which children with asthma are identified. In Arm 2, children with asthma are identified and given written Asthma Action Plans (monitoring). Arm 3 consists of surveillance, monitoring, and education.
- Conditions
- Asthma
- 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 |
|---|---|---|
| South Bronx, Harlem, Lower East Side | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionFeb 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sebastian Bonner, PhD, Principal investigator, The New York Academy of Medicine, CUES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201071
- Sponsor's protocol ID
- 1298
- Other IDs
- R01HL076592
- Status last verified
- Apr 2007
- First submitted
- 12 Sep 2005
- Last updated
- 28 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Surveillance and Education in Preschool Settings
- ClinicalTrials.gov ID
- NCT00201071
- Acronym / sponsor ID
- 1298
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2004
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 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.
The purpose of this study is to test the effectiveness of a bilingual intervention in improving asthma care for low-income inner-city children enrolled in subsidized preschool childcare programs.
Detailed description
BACKGROUND:
Proposed is a non-randomized, controlled, prospective trial to test the efficacy of a bilingual intervention to improve asthma care for low-income inner-city children enrolled in subsidized preschool childcare programs. Because of high rates of asthma prevalence, subsidized preschool childcare programs offer ideal settings to test innovative strategies to improve asthma care within communities at highest risk of morbidity.
DESIGN NARRATIVE:
The study will comprise three arms. Arm 1 is surveillance, in which children with asthma are identified. In Arm 2, children with asthma are identified and given written Asthma Action Plans (monitoring). Arm 3 consists of surveillance, monitoring, and education.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| South Bronx, Harlem, Lower East Side | – | – |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- We formed collaborative agreements with subsidized day care providers in three New York City communities with high asthma prevalence. These three communities - Harlem, the South Bronx and the Lower East Side - are economically disadvantaged communities of color. Participants were parents or guardians of children with asthma enrolled in subsidized day care center. 95% of participants were female, 64% were Hispanic, 25% were Black, 1% were White and 10% were Other. 70% were born in the continental USA, 70% spoke English as their primary language. 30% had earned less than a HS degree, 32% had received a HS diploma or a GED, 37% had attended som college, and 1% had completed college. 33% of participants had family incomes of less than $1,000 per month, 35% had incomes of $1,000 to $1,999 and 32% had incomes over $2,000.
Key inclusion criteria (4 listed)
- Enrolled in specific subsidized preschools in New York City
- 2.8 to 4 years old
- Persistent asthma as defined by symptom reports
- Use of quick-relief agents or controller medications
Key exclusion criteria (1 listed)
- History of intubation
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
Not reported in the source record.
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 28 Sep 2016.
- Click here for the New York Academy of Medicine websiteLink provided by the sponsor.
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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.
Sebastian Bonner, PhD principal investigator
The New York Academy of Medicine, CUES
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 National Heart, Lung, and Blood Institute (NHLBI) 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 4 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 28 Sep 2016. 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.
Where can I read the original study information?
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 28 Sep 2016.