Home-Centered Comprehensive Care (HCCC) for Children With Severe Asthma: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Medical treatment outside of home
研究概览
简要总结
The purpose of this study is to assess whether comprehensive care enhanced with new technology to optimize asthma care in the home (using both a special sensor to track inhaler use and a hand-held PIKO-1 device to assess patients' forced expiratory volume in the 1st second [FEV1]) is effective in reducing total days when medical treatment is given outside the home (in clinic, emergency department, or hospital) among children with severe asthma receiving comprehensive care.
详细描述
BACKGROUND INFORMATION
Asthma is the most common pediatric chronic disease. Despite the understanding of its pathophysiology and the availability of effective therapies, adverse effects on health, school attendance, academic achievement, and family life remain high, particularly among children with severe asthma in minority or low income families.
Innovative new approaches are needed. One innovation that have shown to be cost-effective in high-risk chronically ill children, including children with severe asthma, is care in an enhanced medical home, our High-Risk Comprehensive Care (HRCC) which was designed to optimize care in medical settings. The innovation to be pilot-tested in the proposed research is Home-Centered Comprehensive Care (HCCC) designed to also optimize care in the home and thereby reduce clinic visits and school absences and further decrease Emergency Department visits and hospital days. The proposed HCCC trial builds on the infrastructure, cell phone access to the child's primary caregivers at any hour, and improved outcomes established in our previous HRCC trial (clinicaltrials.gov Identifier: NCT02128776.
DESIGN
Pilot trial of 80 children (2-18 years of age) with uncontrolled severe asthma randomized to either:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with severe asthma (poorly controlled by NIH guidelines ) who meet the inclusion criteria for HRCC (>3 ED visits, >2 hospitalizations, or >1 pediatric ICU admission in past as well as a >50% estimated risk of hospitalization in next yr).
排除标准
- •other major lung disease (e.g. cystic fibrosis or bronchopulmonary dysplasia) or neuromuscular impairment.
结局指标
主要结局
Medical treatment outside of home
时间窗: 2 years
Total number of days when medical treatment was given outside the home (in a clinic, ED, or hospital). Measured by parent report every 3 months for both groups.
次要结局
- Days of missed school(2 years)
- Pulmonary Function Tests. (PFTs)(2 years)
- Parental Satisfaction(2 years)
- Total costs of clinic and hospital care(2 years)
- Physician Services Cost to Reimbursement(2 years)
研究者
Ricardo A. Mosquera
Assistant Professor of Pediatrics
The University of Texas Health Science Center, Houston