Physiological and Environmental Data in a Remote Setting to Predict Exacerbation Events in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- To assess the volume and quality of the data collected in terms of:
研究概览
简要总结
The study plans to monitor around 300 people from different hospitals with COPD for a period of 3 months after they are discharged from the hospital using a smartphone app and a Fitbit device. This device can passively track certain health metrics; this way the research team can research whether it is possible to identify the early warning signs of a decline in health by using these ongoing measurements of vital signs and symptoms. This could allow doctors to intervene early and potentially prevent further deterioration in health decline and hospital admission altogether.
The study seeks to investigate how similar these physiological measurements are when collected in the real world rather than just in the hospital setting, and what influence environmental factors have on a patient's health and experience of their condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 or over.
- •Diagnosis of COPD, currently admitted to hospital and clinically stable with a confirmed acute exacerbation of COPD.
- •Ownership of a smartphone (iOS version 13 or above, Android version 8 or above).
- •Able to provide informed consent to participate in study.
排除标准
- •Patients who require less than 24 hours in hospital at initial visit.
- •Patients deemed unlikely to cooperate with study requirements.
- •Patients with implantable devices.
- •Patient not felt to be suitable for research enrolment by admitting clinical team.
- •Patients requiring non-invasive ventilation or deemed to have a life-expectancy of less than 90 days following discharge.
结局指标
主要结局
To assess the volume and quality of the data collected in terms of:
时间窗: 3 months
Total number of subjects: number of subjects who completed the on boarding stage of the study
次要结局
- To ascertain whether marked physiological events can be detected using smartphone and connected device sensors in a remote setting.(3 months)
- To assess the relationship between patient-generated data gathered from smartphone and connected devices and conventional clinical measures at point of readmission.(3 months)
- To assess the change in passively generated data at the time of further community intervention (HCP review and/or prescription for corticosteroids or antibiotics).(3 months)
- To assess the relationship between patient-generated data gathered from smartphone and connected devices and patient reported functional status.(3 months)
- To evaluate the usability and acceptability of patient-generated data gathered from smartphone and connected devices in a remote setting in patients with COPD.(3 months)