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Asthma Surveillance and Education in Preschool Settings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00201071
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)

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
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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
Current Responsible Party National Heart, Lung, and Blood Institute (NHLBI)
Original Responsible Party Not Provided
Current Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Original Study Sponsor Same as current
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