HealthSpark 2: Improving Asthma Care for Preschool Children
Recruitment status was Active, not recruiting
|First Received Date ICMJE||March 16, 2006|
|Last Updated Date||April 19, 2007|
|Start Date ICMJE||February 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00304304 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||HealthSpark 2: Improving Asthma Care for Preschool Children|
|Official Title ICMJE||Not Provided|
From a previous community needs survey, we determined that asthma was a particular problem in our community-based research network of child care centers. This study will examine whether a moderate intervention can help these centers improve their "asthma-friendly" rating as per NHLBI guidelines. We will both center directors and parents to establish baseline data on child health and the "asthma-friendliness" of each center. We will use a wait-list control, with all centers eventually receiving the intervention.
Asthma is the most common chronic health problem affecting children in the U.S., and it is getting worse. Children under the age of 18 years account for one third of the nation’s asthma sufferers. The percent of children with asthma has increased from 3% in 1981 to 6% in 2003. Asthma is a leading reason for hospitalizations of children under the age of 15 years and causes 14 million days of missed school each year. Previous studies suggest particularly high asthma rates among Hispanic and African-American populations. Poverty, increased exposure to indoor allergens, low education level, poor access to healthcare, and failure to take prescribed medicines increase the likelihood of having a severe asthma attack, or dying of asthma.
According to the results of HealthSpark I, children in the target communities have rates of asthma that are more than three times the national average. 29.3% of HealthSpark families with children ages 3 to 5 years responded “yes” to the question, “Did a doctor ever tell you that your child has asthma?” In a national survey in 2002, only 7.3% of parents with children ages 0 to 4 years responded “yes” to the same question. The high rate of asthma among HealthSpark families is similar to recent reports of high prevalence in Harlem, NY, and other underserved, minority communities.
Of HealthSpark parents reporting that their child has asthma, 38.7% also reported that their child was taking a medication regularly for more than a year. It is reasonable to assume that most of these were asthma medications, which suggests that approximately 11.3% of the total HealthSpark population has moderate to severe asthma. These children also had high rates of comorbidity. HealthSpark children with asthma were twice as likely as children without asthma to be limited in their daily activities, and three times as likely to require increased medical, educational, and mental health services. HealthSpark children with asthma were also two to three times as likely than children without asthma to have early signs of attention deficit hyperactivity disorder (ADHD).
Our analysis also revealed ethnic differences in asthma prevalence consistent with national patterns. African American children were nearly twice as likely to have a diagnosis of asthma when compared with Hispanic children (40.6% vs. 23%). None of these findings were related to access to child health care. Children with asthma, in fact, had better access to care than children without asthma, as demonstrated by the following measures: having a regular source of care (99.4% vs 91%), having health insurance (92.5% vs. 88.6%), and having a regular doctor that their parents could name (94.0% vs. 86.5%). Children with moderate/severe asthma had even better access to care: 98.4% of parents could name their physician and 97% had health insurance for their child.
In 1989, the National Asthma Education and Prevention Program (NAEPP) was initiated by the National Heart, Lung, and Blood Institute (part of the NIH) to address the growing problem of asthma in the United States. To accomplish these broad program goals, the NAEPP works with intermediaries including major medical associations, voluntary health organizations, and community programs to educate patients, health professionals, and the public. The ultimate goal of the NAEPP is to enhance the quality of life for patients with asthma and decrease asthma-related morbidity and mortality. As part of this broad program, the NHLBI released guidelines for CCCs to provide optimal care for children with asthma. These “asthma-friendly” guidelines are at the core of this proposal.
This project is a community-based intervention to begin to improve asthma care among these preschool children. The target population is 2000 children aged 1-5 years who attend the 51 child care centers that remain as part of the SPARK network.
The long-term goals of this project are to (a) improve the health of children by improving asthma care in the targeted, underserved areas of Miami-Dade County and (b) to enhance readiness for school by reducing the burden of asthma and related conditions.
The specific objectives for this project are:
Baseline correlations to identify significant relationships among individual characteristics including asthma severity, healthcare utilization, healthcare access, comorbidity, quality of life, environmental exposures, maternal health literacy, and maternal education
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
|Intervention ICMJE||Behavioral: Asthma education|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Completion Date||July 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||1 Year to 5 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00304304|
|Other Study ID Numbers ICMJE||2005-7395|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Miami|
|Information Provided By||University of Miami|
|Verification Date||April 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP