Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Asthma Surveillance and Education in Preschool Settings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00201071
First received: September 12, 2005
Last updated: September 27, 2016
Last verified: April 2007
History of Changes

September 12, 2005
September 27, 2016
September 2004
February 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00201071 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Asthma Surveillance and Education in Preschool Settings
Asthma Surveillance and Education in Preschool Settings
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.

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.
Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Asthma
Not Provided
South Bronx, Harlem, Lower East Side
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
208
January 2011
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of intubation
Both
2 Years to 4 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201071
1298, R01HL076592
Not Provided
Not Provided
Not Provided
National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: Sebastian Bonner, PhD The New York Academy of Medicine, CUES
National Heart, Lung, and Blood Institute (NHLBI)
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP