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Asthma Surveillance and Education in Preschool Settings
This study has been completed.
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
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
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | |||
| Last Updated Date | September 27, 2016 | |||
| Start Date ICMJE | September 2004 | |||
| Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE | Not Provided | |||
| Original Primary Outcome Measures ICMJE | Not Provided | |||
| Change History | Complete list of historical versions of study NCT00201071 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE | Not Provided | |||
| Original Secondary Outcome Measures ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | Asthma Surveillance and Education in Preschool Settings | |||
| Official Title ICMJE | 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. |
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| Study Type ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Family-Based Time Perspective: Prospective |
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| 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 ICMJE | Asthma | |||
| Intervention ICMJE | Not Provided | |||
| Study Groups/Cohorts | South Bronx, Harlem, Lower East Side | |||
| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 208 | |||
| Completion Date | January 2011 | |||
| Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 2 Years to 4 Years (Child) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00201071 | |||
| Other Study ID Numbers ICMJE | 1298 R01HL076592 ( US NIH Grant/Contract Award Number ) |
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| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | National Heart, Lung, and Blood Institute (NHLBI) | |||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | National Heart, Lung, and Blood Institute (NHLBI) | |||
| Verification Date | April 2007 | |||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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