Asthma Surveillance and Education in Preschool Settings

• ClinicalTrials.gov Identifier: NCT00201071
• Recruitment Status: Completed
• First Posted: September 20, 2005
• Last Update Posted: September 28, 2016
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• 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
• 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

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

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