Asthma Action at Erie Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 223
- 试验地点
- 2
- 主要终点
- Asthma Control Test/Childhood Asthma Control Test at 12-months
研究概览
简要总结
The Asthma Action at Erie Trial compares the current best practice in asthma self-management education (certified asthma educator services) to an integrated community health worker (CHW) home intervention in which the real-life challenges of patients and the health care system are taken fully into account. This trial will provide clarity as to the expected effect size, cost savings, and resources needed to integrate asthma CHWs into clinical practice.
详细描述
The Asthma Action at Erie Trial will test the ability of a community health worker (CHW) intervention with three important modifications to achieve asthma control in high-risk children. These modifications are: 1) CHWs will be integrated into both the clinical and the home setting, 2) A system for directly addressing mental health and psychosocial barriers will be provided, and 3) Participants will be provided only materials and equipment for trigger remediation that are supported by the current medical reimbursement system. To test this intervention, a two-arm behavioral randomized controlled trial (N=220) will be conducted in partnership with a federally-qualified health center (FQHC) serving a low income, minority population that is at high-risk for significant asthma morbidity. The intervention arm will receive an integrated CHW home intervention for pediatric asthma education. The comparison arm will received clinic-based certified asthma educator (AE-C) services. Primary Aim 1 is to assess the efficacy of the integrated CHW home asthma intervention, relative to clinic-based AE-C education over 12-months, as demonstrated by asthma control. Specific Aim 2 is to assess maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months after randomization. Specific Aim 3 is to determine the cost-effectiveness at 12-months of CHW and AE-C intervention delivery, and additional costs or savings related to asthma exacerbations at 12- and 24-months. Specific Aim 4 is to assess the efficacy of the integrated CHW home asthma intervention relative to clinic-based AE-C education, as demonstrated by asthma control, among those experiencing depression, stress, and/or a post-traumatic stress disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child is a patient at Erie Family Health Center
- •Child is age 5-16 at the start of the study
- •Child lives with the index caregiver at least 5 days out of the week
- •Child has uncontrolled asthma. This is defined as a score of 1.25 or greater on the Asthma Control Questionnaire, or report of oral corticosteroid use in the past year
- •Family has a working telephone
排除标准
- •Exclusion criteria include family not fluent in English or Spanish, family lives in temporary housing such as a shelter, caregiver does not have permanent custody of child, or child has significant developmental delays or co-morbidities that would limit their ability to participate in the program.
结局指标
主要结局
Asthma Control Test/Childhood Asthma Control Test at 12-months
时间窗: assessed 12-months from baseline, assessed over past 4 weeks
Asthma Control Test (12 years or older) or Childhood Asthma Control Test (under 12 years old) minimum 5, maximum 27, higher score means better asthma control
Activity Limitation at 12-months
时间窗: assessed 12-months after baseline, assessed over past 14 days
Days of activity limitation over past 14 days minimum 0, maximum 14, higher means worse asthma control
次要结局
- Asthma Control Questionnaire at 12-months(assessed 12-months after baseline, prior week assessed)
- Health Care Utilization at 12-months(assessed 12-months after baseline, assessed from baseline to 12-months)
- Costs of Intervention Delivery(assessed 12-months from baseline, assessed from baseline to 12-months)
研究者
Molly A. Martin
Associate Professor
University of Illinois at Chicago