Tailored Asthma Management for Urban Teens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Asthma-related morbidity
研究概览
简要总结
The purpose of this project is to refine and further evaluate an online asthma management and education program for urban teenagers. This project is a continuation of Puff City I, a project piloting and evaluating a tailored, school-based, computerized asthma education program for urban teenagers. In this second phase of research, a new version of software (Puff City II) will be created that will target resistance to change and relapse, and using a tested, theory-based approach to student recruitment, conduct a randomized trial to test the efficacy of this new software.
详细描述
BACKGROUND:
Teenagers are among an age group that has seen dramatic increases in deaths from asthma. In Detroit, asthma death rates for teenagers are high relative to younger ages, despite a higher prevalence in the latter age group. Early studies suggest that inadequate asthma management plays a significant role in these grim statistics.
DESIGN NARRATIVE:
The study hypothesis is that students randomized to the intervention group will have lower asthma-related morbidity as determined by fewer emergency department visits and hospitalizations at the time of the 12-month follow-up. Based on a second hypothesis of better functional status among students randomized to the intervention group, secondary outcomes include fewer symptom-days, symptom-nights, school days missed, and days of restricted activity at the time of the 12-month follow-up. In addition, it is hypothesized that students in the intervention group will have higher scores on the Juniper Pediatric Quality of Life scale at 12 months. Finally, it is hypothesized that intervention students would exhibit positive changes in adherence behavior, having a rescue inhaler nearby, and smoking at the 12-month follow-up.
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
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A physician diagnosis of asthma AND recent asthma symptoms, health care utilization for asthma, and/or use of medication (or refills of medication) to alleviate asthma symptoms OR
- •No physician diagnosis of asthma AND positive responses to items selected from the International Study of Asthma and Allergy in Children (ISAAC) survey AND asthma symptoms similar to those used in the Expert Panel II for classification of mild intermittent asthma
排除标准
- •Does not meet asthma symptom criteria
结局指标
主要结局
Asthma-related morbidity
时间窗: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
次要结局
- Symptom-days(Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
- Symptom-nights(Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
- School days missed(Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
- Days of restricted activity(Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest)
研究者
Christine Joseph
Senior Scientist
Henry Ford Health System