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: August 10, 2016
Last verified: April 2007
  Purpose
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.

Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Asthma Surveillance and Education in Preschool Settings

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Enrollment: 208
Study Start Date: September 2004
Study Completion Date: January 2011
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
South Bronx, Harlem, Lower East Side

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.

  Eligibility

Ages Eligible for Study:   2 Years to 4 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201071

Locations
United States, New York
The New York Academy of Medicine, CUES
New York, New York, United States, 10029
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Sebastian Bonner, PhD The New York Academy of Medicine, CUES
  More Information

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00201071     History of Changes
Other Study ID Numbers: 1298  R01HL076592 
Study First Received: September 12, 2005
Last Updated: August 10, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 29, 2016