AzTrials
AzTrials

AsthmaNCT00304304

HealthSpark 2: Improving Asthma Care for Preschool Children

A study testing Asthma education in people with Asthma, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year to 5 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
Asthma education
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,000 participants
Where
1 siteUnited States
Study dates
Feb 2006to Jun 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Children ages 1 - 5 years, enrolled in one of the designated SPARK child care centers

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Miami Mailman Center for Child Development

    Miami, Florida, 33101

Other trials in United States

About this study

Official title: Community - Based Asthma Intervention in Subsidized Preschools

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.

Read the 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:

  1. 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.
  2. Identify barriers to optimal asthma care in these children.
  3. 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).
  4. Work with CCCs and community health clinics to improve clinical outcomes for children with asthma.

Outcomes

  1. We will better understand the prevalence, severity, and impact of asthma among preschool children in underserved communities (parent surveys).
  2. We will identify barriers to optimal, community-based asthma care projects (parent surveys and CCC survey).
  3. We will increase the number of CCCs that are "asthma-friendly" (CCC surveys, site visit).
  4. We will improve clinical outcomes for children with asthma (parent survey).
  5. 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

Conditions
Asthma
Being tested
Asthma education
Keywords
child care centers, asthma triggers, community-based research
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Asthma educationBehavioural

    Research assistant worked with CCC staff on asthma prevention

Study groups in NCT00304304
Study groupRoleWhat they receive
Intervention - asthma educationActive comparatorCCC received asthma education in the first 6 months of the study
Receives: Behavioral: Asthma education
Wait-list controlPlacebo comparatorCCC received asthma education in second 6 months of study
Receives: Behavioral: Asthma education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 month post-intervention: quality of CCC asthma policy

    Did CCC have appropriate policy

    Measured: 6 months

Secondary outcomes (1)
  1. 6 month post-intervention changes in asthma outcomes

    Parent-report of fewer asthma symptoms

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionDec 2006
  4. Study completionJun 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00304304
Sponsor's protocol ID
20057395
Status last verified
Feb 2016
First submitted
16 Mar 2006
Last updated
17 Feb 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Asthma education in people with Asthma, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 month post-intervention: quality of CCC asthma policy (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in