Improving Asthma Care for Minority Children in Head Start
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 2
- 主要终点
- Symptom-free days
研究概览
简要总结
This study will evaluate two interventions that are designed to reduce asthma morbidity and improve asthma care of children in Head Start in urban Baltimore.
详细描述
BACKGROUND:
Asthma-related morbidity and mortality are disproportionately high among low-income African American children. The effects of asthma are particularly harsh in 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 and regular asthma preventive care for children, this goal has proved elusive. Head Start programs offer an ideal venue for accessing high-risk, low-income preschool children and improving asthma morbidity. The study will test 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 caregiver's asthma management practices. The study will remove barriers by the use of 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:
This two times two modified factorial study design will compare the following in their effectiveness in reducing asthma morbidity and improving asthma management: a Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI); a FACI alone; the Breathmobile intervention alone; or a control group. A total of 360 Head Start students ages 2 to 6 with symptomatic doctor-diagnosed asthma will be recruited. The primary study outcome measure will be the number of symptom-free days over a period of 12 months. Secondary outcomes include health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits), asthma medications, parent asthma-related quality of life, parent asthma management practices, and cost-effectiveness. The study will test the hypothesis that a FACI combined with the Breathmobile intervention will be the most effective in improving parent and PCP management of the child's asthma and in reducing asthma morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma or reactive airway disease (RAD) OR
- •Experienced asthma symptoms within 1 month prior to study entry
- •Treated for asthma in the emergency department within 6 months prior to study entry
- •Asthma symptoms include day or nighttime wheezing, shortness of breath and cough, or use of rescue medicine (e.g., albuterol or ventolin)
排除标准
- •Currently participating in another asthma education research study
研究组 & 干预措施
4
Control group
1
Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI)
干预措施: Facilitated Asthma Communication Intervention (FACI) (Behavioral)
1
Breathmobile intervention combined with a Facilitated Asthma Communication intervention (FACI)
干预措施: Breathmobile intervention (Behavioral)
2
FACI intervention
干预措施: Facilitated Asthma Communication Intervention (FACI) (Behavioral)
3
Breathmobile intervention
干预措施: Breathmobile intervention (Behavioral)
结局指标
主要结局
Symptom-free days
时间窗: Measured at baseline, 6 months and 12 months
次要结局
- Health care utilization (i.e., emergency department visits, hospitalizations, and primary care visits)(Measured at baseline, 6 months and 12 months)
- Asthma medications(Measured at baseline, 6 months and 12 months)
- Parent asthma-related quality of life(Measured at baseline, 6 months and 12 months)
- Parent asthma management practices(Measured at baseline, 6 months and 12 months)
- Cost-effectiveness(Measured at 12 months)
