Asthma Surveillance and Education in Preschool Settings

Tracking Information
First Submitted Date	September 12, 2005
First Posted Date	September 20, 2005
Last Update Posted Date	September 28, 2016
Study Start Date	September 2004
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00201071 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Asthma Surveillance and Education in Preschool Settings
Official Title	Asthma Surveillance and Education in Preschool Settings
Brief 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.
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 Type	Observational
Study Design	Observational Model: Family-Based; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
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.
Condition	Asthma
Intervention	Not Provided
Study Groups/Cohorts	South Bronx, Harlem, Lower East Side
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: August 10, 2016)	208
Original Enrollment	Not Provided
Actual Study Completion Date	January 2011
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	2 Years to 4 Years (Child)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00201071
Other Study ID Numbers	1298; R01HL076592 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Heart, Lung, and Blood Institute (NHLBI)
Study Sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Collaborators	Not Provided
Investigators	Principal Investigator: Sebastian Bonner, PhD The New York Academy of Medicine, CUES
PRS Account	National Heart, Lung, and Blood Institute (NHLBI)
Verification Date	April 2007