HealthSpark 2: Improving Asthma Care for Preschool Children
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma education
Sponsored by

About this trial
This is an interventional prevention trial for Asthma focused on measuring child care centers, asthma triggers, community-based research
Eligibility Criteria
Inclusion Criteria: Children ages 1 - 5 years, enrolled in one of the designated SPARK child care centers Exclusion Criteria: Children under the age of 1 year Children whose parents do not want to participate Children whose child care centers do not want to participate
Sites / Locations
- University of Miami Mailman Center for Child Development
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention - asthma education
Wait-list control
Arm Description
CCC received asthma education in the first 6 months of the study
CCC received asthma education in second 6 months of study
Outcomes
Primary Outcome Measures
6 month post-intervention: quality of CCC asthma policy
Did CCC have appropriate policy
Secondary Outcome Measures
6 month post-intervention changes in asthma outcomes
Parent-report of fewer asthma symptoms
Full Information
NCT ID
NCT00304304
First Posted
March 16, 2006
Last Updated
February 14, 2016
Sponsor
University of Miami
Collaborators
Health Foundation of South Florida, Ounce of Prevention Fund, The Early Childhood Initiative Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00304304
Brief Title
HealthSpark 2: Improving Asthma Care for Preschool Children
Official Title
Community - Based Asthma Intervention in Subsidized Preschools
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Health Foundation of South Florida, Ounce of Prevention Fund, The Early Childhood Initiative Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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:
Document the prevalence, severity, and impact of asthma among preschool children attending the 51 SPARK child care centers (CCCs) in Allapatah/Model City and Homestead/Florida City.
Identify barriers to optimal asthma care in these children.
Determine how "asthma-friendly" each child care center is according to guidelines of the National Heart, Lung, and Blood Institute (part of the NIH) (see Appendix I).
Work with CCCs and community health clinics to improve clinical outcomes for children with asthma.
Outcomes
We will better understand the prevalence, severity, and impact of asthma among preschool children in underserved communities (parent surveys).
We will identify barriers to optimal, community-based asthma care projects (parent surveys and CCC survey).
We will increase the number of CCCs that are "asthma-friendly" (CCC surveys, site visit).
We will improve clinical outcomes for children with asthma (parent survey).
We will increase the number of children with written asthma plans from an estimated 10% to greater than 50%.
Other outcomes:
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
child care centers, asthma triggers, community-based research
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention - asthma education
Arm Type
Active Comparator
Arm Description
CCC received asthma education in the first 6 months of the study
Arm Title
Wait-list control
Arm Type
Placebo Comparator
Arm Description
CCC received asthma education in second 6 months of study
Intervention Type
Behavioral
Intervention Name(s)
Asthma education
Intervention Description
Research assistant worked with CCC staff on asthma prevention
Primary Outcome Measure Information:
Title
6 month post-intervention: quality of CCC asthma policy
Description
Did CCC have appropriate policy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
6 month post-intervention changes in asthma outcomes
Description
Parent-report of fewer asthma symptoms
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children ages 1 - 5 years, enrolled in one of the designated SPARK child care centers
Exclusion Criteria:
Children under the age of 1 year
Children whose parents do not want to participate
Children whose child care centers do not want to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey P Brosco, MD PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Mailman Center for Child Development
City
Miami
State/Province
Florida
ZIP/Postal Code
33101
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HealthSpark 2: Improving Asthma Care for Preschool Children
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