Observational Study: Oxygen Therapy Monitoring in COPD Patients Using Connected Devices.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 161
- 试验地点
- 33
- 主要终点
- Assessment of compliance of long term oxygen therapy
研究概览
简要总结
Background : Long-term oxygen therapy is prescribed for patients with severe COPD. The aim of oxygen therapy is to administer oxygen at a concentration level higher than that of ambient air, in order to treat or prevent the symptoms and manifestations of arterial hypoxemia; this therapy can be applied either in an acute situation or as a long-term treatment, in cases of stabilized severe chronic hypoxemia.
Currently, pneumologists do not have the possibility, between 2 consultations spaced several months apart, to measure the patient's compliance with the treatment (adherence to oxygen therapy) nor the respect of the prescribed dosage (O2 flow and duration). In addition to the patient's adherence to the treatment, the specialist does not have the possibility to assess the patient's physical activity (walking ...).
This observational study is a e-health, prospective, multicenter study conducted in France under the control of pneumologists.
The main objective of this study is to evaluate the adherence to oxygen therapy in real life, and its evolution, in COPD patients justifying a long term oxygen therapy in stable state.
详细描述
The observational study consists in collecting physiological data (cardiorespiratory and physical activity) and use of the oxygen therapy device in real life during the first months after the initiation of treatment.
For this purpose, two connected medical devices will be provided to each patient during 2 periods of 2 weeks (weeks 6 to 8 then weeks 12 to 14 after the initiation of oxygen therapy). The devices are: 1/ a connected watch that continuously measures vital parameters (heart rate and blood oxygen saturation), and physical activity parameters (no. of steps, distance, duration of effort), and 2/ a Teleox device that remotely monitors patients equipped with an oxygen source (it measures the oxygen flow rate requested by the patient, the duration of use of the oxygen source, and the breathing rate).
Study design: a cohort of 250 patients with COPD newly initiated a long term oxygen therapy will be enrolled in the study and follow-up over 6 months. Data will be collected by lung specialists and home health care provider teams at 2 months, 3.5 months and 6 months post-initiation of oxygen therapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients who require the initiation of a long term oxygen therapy.
- •Patient agreeing to use a connected watch and a TeleOx for the remote monitoring of their parameters and physical activity.
- •Non-smoker, ex-smoker, or patient agreeing to stop smoking.
- •Life expectancy greater than 6 months.
- •Signed informed consent form,
- •Subject affiliated to a health insurance system, or is a beneficiary.
排除标准
- •Patient initiated on oxygen therapy prior to the inclusion visit.
- •Patient with cognitive impairment.
- •Simultaneous participation in a health intervention research,
- •Vulnerable subjects.
结局指标
主要结局
Assessment of compliance of long term oxygen therapy
时间窗: 3.5 months
For each patient, the average daily duration of oxygen use (expressed as numbers of hours of oxygen use per day) will be measured on period of 14 consecutive days at different times after the initiation of oxygen therapy (weeks 6 to 8, and then weeks 12 to 14). The duration of oxygen use is measured using the TeleOx medical device placed in each oxygen source (fixed and portable sources).
次要结局
- Impact of long term oxygen therapy on the physical activity in terms of duration of effort(Month 2, Month 3.5)
- Impact of long term oxygen therapy on the respiratory rate(Month 2, Month 3.5)
- Impact of long term oxygen therapy on the health related quality of life of COPD patients(At oxygen therapy initiation (baseline), Month 2, Month 3.5)
- Impact of long term oxygen therapy on the respiratory function(At inclusion, Month 6)
- Assessment of exacerbation(Month 6)
- Impact of long term oxygen therapy on heart rate(Month 2, Month 3.5)
- Impact of long term oxygen therapy on oxygen saturation in the blood (SpO2)(Month 2, Month 3.5)
- Impact of long term oxygen therapy on the physical activity in terms of duration of number of steps(Month 2, Month 3.5)