NCT06419036Enrolling By Invitation不适用
The Use of Medical Devices to Monitor COPD Patients Study - An Observational Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical changes before COPD exacerbations
研究概览
简要总结
The proposed study will explore whether remote monitoring of a COPD patient can be undertaken using a wearable medical device.
详细描述
The proposed study will assess the sensitivity of a wearable device to measure the respiratory signals in COPD patients, who have previously experienced hospitalisation due to exacerbation of their COPD. Participation in the study involves wearing a small sensor. The monitoring device will also assess the effectiveness of medication prescribed before, during, and after the COPD exacerbation to see if it has a role in directing day-to-day therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Any person aged 18 years or over.
- •Current diagnosis of COPD.
- •Be willing and able to comply with study procedures and be available for study visits. • Be able to use a 'smartphone or computer'.
- •Be able to give written consent.
- •Able to understand written and spoken English.
排除标准
- •Inability to give written informed consent.
- •Known respiratory disorders are other than COPD which, in the opinion of the investigator, is the main contributor to the patient's symptoms (e.g. asthma, lung cancer, sarcoidosis, and other interstitial lung diseases (ILDs), tuberculosis, lung fibrosis, cystic fibrosis, and non-COPD related bronchiectasis).
- •Known history of significant systemic and other organ-related diseases, other than COPD, which in the opinion of the investigator, is likely to interfere with the study or impact on subject safety (e.g. severe rheumatoid arthritis and Lupus, kidney, liver, endocrine, psychological disorders).
- •Known to be severely alpha-1-antitrypsin deficient (PI, SZ or ZZ).
- •Based on their medical record if there is any social violence/substance misuse.
- •Having undergone lung surgery (e.g. lung volume reduction, lobectomy) within the last 6 months.
- •Have cancer or other terminal condition which, in the opinion of the investigator, has a mortality of 12 months or less. • Have, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse.
- •Taking high-dose oral corticosteroid medication (equivalent to daily dose of ≥10 mg of prednisolone) for more than 3 consecutive months.
- •Pregnancy
- •Patients already involved in an ongoing research study.
- •Participation in an interventional clinical study within 3 months of Visit 1 or participation in a study using an investigational medicinal product (IMP) either in the previous 3 months or in the interval from last using the IMP to 5 times its half-life.
- •Patients with other significant lung disease, unable to consent, unable to use the technology (e.g. inability to use the data device, or complete the questionnaires), or at the clinician's discretion for other more significant medical/social reasons.
- •Known allergy to surgical adhesive tape.
- •On long-term oxygen therapy.
- •Acute exacerbation of COPD within 6 weeks prior to inclusion.
结局指标
主要结局
Clinical changes before COPD exacerbations
时间窗: 18 months
Participants' breath rates will be measured through chest movement in their daily lives, and clinical changes in their breath rates will be examined.
次要结局
- Device usage(18 months)
研究者
研究点 (1)
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