An Exploratory,Observational, Non-interventional, Open Label, Remote Pilot Study to Assess Adherence in Study Subjects With COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Spire, Inc.
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Spire wearable health monitor physiological data collection
研究概览
简要总结
The purpose of this study is to monitor adherence to a clothing-attached breathing monitor, respiratory patterns, and activity levels in COPD patients, and correlate those respiratory patterns and activity levels with patient-reported symptoms and events. To achieve this purpose, Spire will collect data from a wearable monitor that participants attach to the participant's clothing, an associated smartphone application, and completion of weekly questions. The wearable monitor and the consumer smartphone application to be used are consumer products and currently available in the market.
This study does not include clinical intervention and no doctors will be involved in this study.
No clinical tests or office visits are included in this study. All data will be collected through an online survey tool and remotely through the wearable sensors.
详细描述
This is an exploratory, observational, non interventional, single-arm, open label, remote pilot study involving up to 150 self-reported COPD participants. Eligible participants will wear the Spire biophysiological health monitors for a period of 9 months while the participants report symptoms on a weekly basis via brief surveys. If and when participants incur a COPD-related exacerbation which results in a medication change after hospitalization or contact with a healthcare provider, participants will report this on the weekly surveys. When this survey is read by a study nurse, the nurse will follow up with the participant by phone to conduct a post-exacerbation phone screening. This data would provide context to inform how to correlate the biosensor-sensed physiological parameters with the exacerbation self-reported data. All study participants will be remotely distributed throughout the United States.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Self-reported diagnosis of moderate to severe COPD
- •>=1 self-reported COPD-related hospitalization within the previous 12 months
- •Currently using an iPhone 6 or newer and willing to install the Spire smartphone app
- •Willing to wear Health Tags 80% of each 24 hour period and answer the email-based self-assessments weekly for the study duration
- •Willing to provide consent to participate and abide by study protocol for study duration (9 months)
- •Must be able to read and understand English
- •Access to Wi-Fi at home and at work, for at least 20 hours per day (and smartphone connected to Wi-Fi throughout the study duration)
排除标准
- •Diagnosed with another medical condition that may confound the respiratory symptoms of COPD (ex: cystic fibrosis, lung cancer, bronchiectasis, idiopathic pulmonary fibrosis, or chest wall deformities).
- •Diagnosed with any neurodegenerative disorder (e,g, Parkinson's, Alzheimer's or Epilepsy)
- •Pregnant at the time of study or expecting to become pregnant throughout the course of the study.
结局指标
主要结局
Spire wearable health monitor physiological data collection
时间窗: weekly email surveys and phone calls over a nine month period
To evaluate the extent to which Spire wearable health monitor can capture viable data from COPD participants
次要结局
- Participant adherence(weekly email surveys and phone calls over a nine month period)