Non-contact Proactive Remote Monitoring to Facilitate Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Understand the patient acceptance of DistaSense
研究概览
简要总结
The goal of this observational study is to determine if a COPD exacerbation can be detected early in its onset. The main questions it aims to answer are:
- Can an exacerbation be detected before the person recognizes they are unwell?
- What are the biological signals which provide the best indication of decompensation?
- How does this indication of decompensation compare to a daily CAT?
Participants will be asked to place a device, DistaSense, on top of their mattress and then sleep as normal. In addition, they will be asked to complete a daily CAT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Confirmed diagnosis of COPD
- •1 or more exacerbation in the last year
- •Aged over 18 years
- •Willing to use monitoring devices and complete study questionnaires
- •Adequate English
- •Signed consent form
排除标准
- •BMI greater than 45 kg/m2
- •Nil other, provided inclusion criteria are met.
结局指标
主要结局
Understand the patient acceptance of DistaSense
时间窗: 12 months
To evaluate the patient acceptance of using DistaSense, a non-contact vital sign monitor that measures heart rate and respiration rate, we will be requesting patients complete a Technology Assessment Model Fast Form (TAM-FF) every 3 months during the 12 month trial period.
Track the adherence of DistaSense
时间窗: 12 months
To evaluate the adherence of patients using DistaSense, a non-contact vital sign monitor that measures heart rate and respiration rate, we will be tracking the patient dropout rate over the course of the 12 month study period.
Ability to detect COPD exacerbations
时间窗: 3 - 12 months
To evaluate the ability of a non-contact remote monitoring techniques to detect exacerbations of COPD.
次要结局
未报告次要终点