CareCOPD - Chronic Obstructive Pulmonary Disease (COPD) Home Monitoring for Early Exacerbation Detection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of AECOPD
研究概览
简要总结
This is a pilot study to demonstrate early validation of objective home-monitoring of Chronic obstructive pulmonary disease (COPD) patients by combining accurate and relevant patient data of medication and lung function (lung impedance) through patient-facing devices.
详细描述
The study goals are to demonstrate early validation of objective home-monitoring of COPD patients using CareCOPD mature devices, paving way for follow-up work of care integration and larger studies. The data will consist of time-series airway obstruction parameters, medication quality, and symptoms data to detect correlations with exacerbation events. 50 COPD patients (diagnosed GOLD 2- 3, C- D for moderate-severe, poorly controlled) will be monitored for 6 months. A successful outcome will be improved acute exacerbation of COPD or AECOPD detection of at least one day earlier than patient-reported assessment (COPD Assessment Test or CAT, modified Medical Research Council or mMRC questionnaires) and false positives of <20%.
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
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all of the following criteria are eligible for enrollment as study participants:
- •Males and females over the age of 40 years.
- •physician-diagnosed COPD classified as GOLD 2-3, C-D for at least 1 year.
- •Using rescue medications at home delivered by a metered-dose inhaler or MDI.
- •Speak, read, and understand English.
- •Able to understand study requirements and comply with study procedures.
- •Ability to operate a smartphone or tablet (for questionnaire and symptoms input).
排除标准
- •Subjects who meet any of these criteria are not eligible for enrollment as study participants:
- •Physically disabled such that they are incapable of performing forced oscillometry test (for airway impedance measurement)
- •Physically disabled such that they are incapable of using metered-dose inhalers.
- •Suffer from any visual, hearing, or cognitive impairment that cannot be corrected enough to operate the CareCOPD devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage.
- •Suffering from serious uncontrolled medical conditions that may interfere with study conduct.
- •Continuous home Oxygen use for greater than 16 hours/day.
- •Inability or unwillingness of the participant to give written informed consent.
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
结局指标
主要结局
Percentage of AECOPD
时间窗: 6 months
Percentage of AECOPDs detected by CareCOPD platform
次要结局
- Average number of days before AECOPD detection(6 months)
- False positivity rate(6 months)