Feasibility and Cost Effectiveness of Physiological Monitoring at Home in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Integrity of spirometric data
研究概览
简要总结
Remote Health Monitoring (RHM) is the assessment of one's own symptoms at home between doctor visits, using things like at-home breathing tests, electronic diaries to answer questionnaires, and other monitoring devices. The hypothesis of this study is that the health and quality of life of people with COPD who do RHM for one year will be better than people with COPD who do not do RHM. Subjects who are at least 40 years old, have been diagnosed with chronic obstructive pulmonary disease (COPD), also known as chronic bronchitis or emphysema, and are current or former smokers will be invited to participate. This study is paid for by eResearch Technology (eRT).
Subjects will complete 2 visits at UCLA, separated by one year of RHM. All subjects will participate in RHM. RHM will involve daily monitoring at home using a few electronic devices: blood oxygen levels, symptoms, medication use, breathing tests, and activity monitoring. Visits will include physical exam and medical history, ECG, questionnaires, breathing tests, and exercise tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Age >40 years.
- •Clinical diagnosis of moderate to severe COPD in accordance with the definition of the American Thoracic Society (ATS).9
- •Smoking history >10 pack-years.
- •Postbronchodilator FEV1/FVC<70% and FEV1<70% based on NHANES III reference values
- •Domestic situation felt to be supportive of remote health monitoring.
- •Ability to give informed consent.
排除标准
- •Clinical diagnosis of asthma.
- •Pulmonary disease other than COPD (e.g., lung cancer, sarcoidosis, active tuberculosis, bronchiectasis, pulmonary fibrosis, cystic fibrosis, or alpha-1-antitrypsin deficiency) or had lung volume reduction.
- •Any other active disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation (e.g. unstable cardiovascular disease, renal failure, stroke).
- •Previously diagnosed cancer is considered a significant disease unless it is in complete remission for 2 years at the initial visit.
- •Any other disease that is life-threatening and carries a prognosis less than two years that, in the opinion of the investigator, is likely to influence the clinical course during the conduct of this trial.
- •Myocardial infarction within 6 weeks of enrolment.
- •Use of long-term oxygen therapy (LTOT) prescribed for greater than 12 hours a day.
- •A known or suspected history of drug or alcohol abuse within 2 years prior to the initial visit.
结局指标
主要结局
Integrity of spirometric data
时间窗: 1 year
Integrity of the spirometric data in terms of the standard American Thoracic Society and European Respiratory Society criteria for acceptability and repeatability.
Compliance with daily RHM
时间窗: 1 year
Compliance with daily RHM as a percentage of study days
次要结局
- Number of days spent in hospital(1 year)
- Number of COPD exacerbations per year(1 year)
- Mean daily FEV1(1 year)
- Number of emergency department visits(1 year)
- Proportion of subjects experiencing one or more exacerbations(1 year)
- Time to first COPD exacerbation(1 year)
- Mean daily IC(1 year)
- Mean daily activity level(1 year)
- Treatment adherence(1 year)
- Number of physician visits(1 year)
- Rate of adoption of RHM(1 year)
- Mean daily SpO2(1 year)
- Daily symptom scores(1 year)
- Number of hospitalizations(1 year)
- Health care costs(1 year)
研究者
Christopher B Cooper, MD
Professor
University of California, Los Angeles