Characterizing the Recovery Phase of Acute Exacerbations of COPD Using Wearable Remote Monitoring Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Daily/nightly respiration
研究概览
简要总结
The purpose the study is to successfully characterize the recovery phase of acute exacerbations of COPD in the outpatient setting using remotely captured physiologic data from wearable devices, to compare this with patient self-reported symptom data, to determine which physiologic variable(s) best correspond with AECOPD recovery, and to further document the feasibility, data quantity, data quality, and COPD outpatient usability experience with wearable devices.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males/females, age ≥40, former/current smokers with ≥10 pack-year smoking history
- •Currently experiencing/receiving treatment for a physician-diagnosed AECOPD
- •Forced expired volume in the first second (FEV1) / Forced vital capacity (FVC) < 0.7 (GOLD 1-4)
- •Ability to provide informed consent
排除标准
- •No existing COPD diagnosis
- •History of cardiac arrhythmia
- •Presence of pacemaker/defibrillator
- •Any medical/cognitive/functional condition which renders inability to don/doff/recharge devices and complete symptom questionnaire
- •Have already received 4 or more days of consecutive corticosteroid and/or antibiotic therapy since presenting to medical attention for their AECOPD
结局指标
主要结局
Daily/nightly respiration
时间窗: Daily for 21 days
Respiratory rate (RR) will serve as the primary independent (predictor) variable, and RR variability will serve as a secondary independent (predictor) variable.
Daily symptom score
时间窗: Daily for 21 days
Validated AECOPD symptom score (EXACT PRO) will serve as the dependent (outcome) variable.
次要结局
- Daily/nightly peripheral body temperature(Daily for 21 days)
- Sleep metrics(Daily (nightly) for 21 days.)
- Daily/nightly heart rate and HR variability(Daily for 21 days)
- Activity(Daily for 21 days)
- Autonomic function/Stress(Daily for 21 days)
研究者
Bryan Ross
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre