SHAPES Advanced Telemonitoring of Patients With COPD in Home Environment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Telemetric spirometry - FVC
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is one of the leading and rising causes of morbidity and mortality worldwide. The most important etiopathogenetic agent is smoking. However, air-pollution probably also plays a crucial role in the disease development, progression and exacerbations. The multimodal-telemedicine approach may provide a useful tool in the patient follow-up with the aim to reduce disease exacerbation rate and improve the health-related quality of life. The study aims to investigate the effects and utility of advanced telemonitoring in elderly COPD patients. All data will be integrated in a single web-based platform in order to analyse the mutual effects of different conditions and variables.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 60 years of age
- •Informed written and verbal consent
- •Ability to participate in study activities
排除标准
- •Active smoking
- •Respiratory failure requiring oxygenotherapy or ventilation support
- •Severe psychological disturbances
- •Absence of collaboration (informed consent)
- •Other comorbid pulmonary disease
- •Symptomatic heart failure
- •Motor neuron diseases (e.g. amyotrophic lateral sclerosis etc.)
结局指标
主要结局
Telemetric spirometry - FVC
时间窗: 3 month
Evaluation of telemetric measurement of FVC in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - PEF
时间窗: 3 month
Evaluation of telemetric measurement of PEF in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - FEV1%
时间窗: 3 month
Evaluation of telemetric measurement of FEV1% in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - FEV1%/FVC ratio
时间窗: 3 month
Evaluation of telemetric measurement of FEV1%/FVC ratio in home enviroment in COPD patients wih use of mobile spirometer
Blood oxygen saturation monitoring
时间窗: 3 month
Continuous measurement of blood oxygen saturation in the study group.
Particulate matter concentration monitoring
时间窗: 3 month
Continuous measurement of both indoor and outdoor air-pollution levels via monitoring of selected parameters (PM1.0, PM2.5, PM4.0, PM10). and some other selected environmental parameters (humidity and temperature) - as well in both outdoor and indoor conditions.
Environmental monitoring
时间窗: 3 month
Continuous measurement of selected environmental parameters (humidity and temperature) - in both outdoor and indoor conditions.
Adherence monitoring - rate of inhalations per day
时间窗: 3 month
The regular monitoring of the patients' adherence to the inhaled therapy, using FindAir smart inhaler technology. Rate of inhalations per day is measured via special cap mounted on the top of the inhaler which is detecting each activation while pressing the cap. Result is being compared with the amount of inhalations recommended by the physician.
Adherence monitoring - time of inhalation deviation
时间窗: 3 month
The regular monitoring of the patients' adherence to the inhaled therapy, using FindAir smart inhaler technology. A specific time of inhalation is being recorded by a special cap mounted on the top of the inhaler which is detecting each activation while pressing the cap. Deviation between recommended time of inhalation and real time of inhalation is being monitored through the study.
次要结局
未报告次要终点
研究者
Ladislav Stanke
Principal Investigator
University Hospital Olomouc