FreeDom：COPD 恶化管理的创新策略
FreeDom：结合早期住院出院、居家自动断氧、远程医疗和远程康复的 COPD 恶化管理创新策略
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.
The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.
研究概览
详细说明
The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy will enable an early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation.
The main hypothesis of this study is that a strategy for an early return home with a home hospitalization managed by telemedicine will reduce the length of hospitalization by 50 percent from 30 days.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
-
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Quebec
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Québec、Quebec、加拿大、G1V4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
All patients hospitalized for COPD exacerbation for less than 48 hours will be considered.
- known or suspected COPD to entry
- Age > or = 40 years
- Ex-smoker history (10 pack / year or more)
- Acute Exacerbation: dyspnea of recent onset (less than 15 days)
- The need for oxygen therapy with a moderate rate: <6L / min to maintain SpO2 > 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home)
Exclusion Criteria:
- Refusal to consent to participate in the study,
- Indication for an imminent intubation according to the pulmonologist,
- Sleep Apnea
- NIV used at home
- Lack of FreeO2 system available at the time of randomization
- Non-autonomous and alone at home
- Patient alone at home
- Patients who live more than 50 km from the hospital
- Patient already included in the study within 3 months
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Control
The intervention is an hospitalization with usual care. The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria |
The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
其他名称：
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有源比较器：FreeDom
FreeDom strategy (early discharge, automated weaning at home, telemedicine, telereadaptation): -initial conventional hospitalization before discharge home, O2 flow rate automatically titrated by FreeO2 (based on a SpO2 target). The hospital discharge will be possible if the definite criteria are met. After hospital discharge, patient will have home hospitalisation. Automated oxygen flow titration, patient education will be conducted for using the telemedicine system, for questionnaires and for the tele-rehabilitation program will be initiated for home hospitalization, |
Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The number of hospital days during COPD exacerbation at day 30.
大体时间：30 days
|
The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation |
30 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of Emergency consultation and hospital readmission
大体时间：1 and 3 months
|
Rate of Emergency consultation and hospital readmission |
1 and 3 months
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Health Related Quality of Life
大体时间：1 and 3 months
|
Survey of health related quality of life |
1 and 3 months
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|
Cost of care at 3 months
大体时间：3 months
|
Economic evaluation about these 2 different strategy of COPD exacerbation management using micro-costing approach and including the cost of the FreeO2 technology |
3 months
|
|
Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)
大体时间：From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
|
The continuous measurement of SpO2 and O2 flow rate with the FreeO2 device (only in the FreeDom strategy) will allow the calculation of the % of time within the SpO2 target (recorded in the FreeO2) ± 2%, with hypoxemia (% of time with SpO2 < 85%) and with hyperoxia (% of time above SpO2 target +5%) |
From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
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Number of consultations
大体时间：3 months
|
Number of consultation : phone call, video consultation, rehabilitation, home visit |
3 months
|
合作者和调查者
调查人员
- 首席研究员：François Lellouche、Laval University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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