ASPIRE: An Observational Study of the Wellinks Solution Impact on Quality of Life and Clinical Outcomes in Patients With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 4
- 主要终点
- Patient-Reported Healthcare Resource Utilization (HRU)
研究概览
简要总结
The clinical objectives of this study are to determine whether utilization of the Wellinks COPD Solution can improve quality of life for patients with COPD, can reduce healthcare resource utilization over time, and can improve pulmonary function as measured by connected devices.
The nonclinical objectives of this study are to describe the experience of patients using the Wellinks Solution through the assessment of patient engagement with the solution, as well as by patient-reported satisfaction with the solution and their perceived value (e.g., willingness to pay). Qualitative feedback on the features and functionality of the Wellinks Solution will be solicited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD diagnosis (confirmed by the patient and assumed based on participation in COPD PPRN)
- •Home telephone (landline or mobile) and internet access
- •Smartphone: iPhone 6S or later model, running iOS 14.0 or later; Android 6 or later model
- •Proficient in English language
- •Living/staying in the United States throughout the study duration
- •Willing and able to comply with study requirements
- •Able to provide written informed consent
排除标准
- •Current participation in other interventional clinical trials
- •Current participation in a pulmonary rehabilitation program
结局指标
主要结局
Patient-Reported Healthcare Resource Utilization (HRU)
时间窗: 24 weeks
Measure of health resource utilization from period 12 to 24 weeks. Emergency room visits. Hospitalizations.
Modified Medical Research Council Dyspnea Scale (mMRC)
时间窗: Change from baseline to 24 weeks
Change in mMRC score. (0-4, 0 is best)
COPD Self-Efficacy Scale
时间窗: Change from baseline to 24 weeks
Change in COPD Self-Efficacy Scale
COPD Symptoms Assessment
时间窗: Change from baseline to 24 weeks
Change in self-reported symptoms as collected in the app.
次要结局
未报告次要终点