Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- Asthma Control Test (ACT)
研究概览
简要总结
The purpose of this study is to evaluate the Puff City web-based behavioral intervention of asthma management program in a clinical setting. This study also examines and evaluates the cost and efficiency of patient eligibility determination methods, patient recruitment, study monitoring (compliance with study regimen, participant retention and follow-up), and the collection of clinical endpoints.
详细描述
Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City).
The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-19 years of age
- •Must be able to provide electronic assent and have consent from a parent/guardian if applicable
- •Diagnosis of asthma by meeting one of the following criteria within the last 12 months:
- •At least one emergency department diagnosis of asthma or
- •At least one acute inpatient encounter with asthma as the principal diagnosis or
- •At least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or
- •At least four asthma medications dispensed
排除标准
- •Inability to provide informed consent/assent
- •Lack of physician diagnosis of asthma
- •Other co-morbidities that make it impossible for the individual to participate.
研究组 & 干预措施
Tailored asthma management program
Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
干预措施: Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management. (Behavioral)
Control
Teens in the control group will receive generic, web-based asthma education.
干预措施: Teens in the control group will receive generic, web-based asthma education. (Behavioral)
结局指标
主要结局
Asthma Control Test (ACT)
时间窗: 12 Months
Comparison of ACT scores at 12 months after the randomization
次要结局
- Asthma Exacerbations/Functional Status(12 Months)
研究者
Dr. Mei Lu
Senior Biostatistician
Henry Ford Health System