Asthma in Children |
Childhood Asthma |
Clinical Trial: Improving Asthma Care for Minority Children in Head Start
This study is not yet open for patient recruitment.
Purpose
To evaluate two interventions to reduce asthma morbidity and improve asthma care for Head Start children in urban Baltimore.
| Condition | Treatment or Intervention |
|---|---|
| Asthma Lung Diseases | Behavior: health education |
MedlinePlus related topics: Asthma; Respiratory Diseases
Study Type: Interventional
Study Design: Prevention, Factorial Assignment
Study start: September 2004; Expected completion: May 2008
BACKGROUND: Asthma-related morbidity and mortality are disproportionately high among low-income African-American children. The impact of this asthma burden is particularly great on very young children and their families, resulting in high rates of emergency department care, hospitalization, decreased quality of life, and the risk of fatal asthma. Research suggests that the contributing factors to this high morbidity include under-use of asthma primary preventive care, sub-optimal medical management, and inappropriate asthma management behaviors. Despite the importance of early, regular asthma preventive care for children this goal has proved elusive. Head Start programs offer an ideal venue for accessing high-risk, low income pre-school children and improving asthma morbidity. The study tests the hypothesis that removing barriers to preventive asthma care and facilitating communication between parents and primary care providers (PCP) are necessary prerequisites to optimally influence caregivers' asthma management practices. The study will remove barriers by use of the Breathmobile, a community-based service that is specifically designed to deliver asthma screening, and special consultation directly to families and children in high-risk neighborhoods. In addition, the study will evaluate a caregiver/PCP communication intervention designed to facilitate communication between parents and PCPs about a child's asthma severity and recommended therapy.
DESIGN NARRATIVE: The 2x2 modified factorial study design will compare the effectiveness of a Breathmobile Intervention combined with a Facilitated Asthma Communication Intervention (FACI) to a Facilitated Asthma Communication Intervention alone, the Breathmobile Intervention alone, or a Control Group in reducing asthma morbidity and improving asthma management. A total of 360 Head Start students ages 3 and 4 with symptomatic doctor-diagnosed asthma will be recruited. The primary study outcome measure will be Symptom-Free Days over 18 months. Secondary outcomes include school absences, health care utilization (emergency department visits, hospitalizations, primary care visits), asthma medications, parents' asthma related quality of life, parent asthma management practices, and cost-effectiveness. The study tests the hypothesis that a Facilitated Asthma Communication Intervention combined with the Breathmobile Intervention will be most effective in improving parent and PCP management of the child's asthma and reducing asthma morbidity.
Eligibility
Ages Eligible for Study: 3 Years - 4 Years, Genders Eligible for Study: Both
Criteria
Location Information
Cynthia Rand, Johns Hopkins University
More Information
Record last reviewed: December 2004
Last Updated: January 10, 2005
Record first received: October 15, 2004
ClinicalTrials.gov Identifier: NCT00094276
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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