Comprehensive Self-Management Support for WTC Responders With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Asthma Control Test (ACT)
研究概览
简要总结
Aim 2: Conduct a pilot RCT of SaMBA-WTC to determine feasibility and preliminary impact in preparation for a fully powered trial. (7M-24M) The investigators will conduct a pilot RCT (n=58) of the SaMBA-WTC model vs. an attention control. Data will be collected on the primary outcomes (asthma control [asthma control test, ACT], medication use, inhaler technique) as well as on other secondary outcomes including measures of physical function, self-management behaviors, feasibility and fidelity at baseline, at intervention completion at 3 months, and for sustainability at 6 months. This project will prepare the team for all aspects of a subsequent larger efficacy trial of SaMBA-WTC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=21 years;
- •English or Spanish speaking;
- •World Trade Center-certified asthma;
- •on asthma controller medications (as needed or standing);
- •uncontrolled asthma.
排除标准
- •Physician's diagnosis of dementia,
- •COPD or other chronic pulmonary disease,
- •>15 pack-years history of smoking to avoid enrolling WTC responders with undiagnosed COPD.
结局指标
主要结局
Asthma Control Test (ACT)
时间窗: 12 months and 3 months post intervention
Asthma control test assesses how well asthma is controlled over the past four weeks. Total score range from 5-25, with higher score indicating better health outcomes.
Number of times controller inhaler used
时间窗: 12 months and 3 months post intervention
Medication use will be measured with electronic monitors attached to the participant's control inhaler. Adherence will be measured by use of the electronic monitors that will capture how often the participant uses their controller inhaler.
次要结局
- Mini Asthma Quality of Life Questionnaire (AQLQ)(12 months and 3 months post intervention)
- Number of Hospital visits(12 months and 3 months post intervention)
- Number of Emergency Department visits(12 months and 3 months post intervention)
研究者
Juan Wisnivesky
Professor
Icahn School of Medicine at Mount Sinai