FreeDom: COPD 악화 관리를 위한 혁신적인 전략
FreeDom: 조기 입원 퇴원, 가정에서의 자동 산소 이유식, 원격 의료 및 원격 재활을 결합한 COPD 악화 관리를 위한 혁신적인 전략
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Québec
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The number of hospital days during COPD exacerbation at day 30.
기간: 30 days
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The objective of the study is to reduced the hospitalisation days by 50 % at day 30 during COPD exacerbation |
30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Rate of Emergency consultation and hospital readmission
기간: 1 and 3 months
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Rate of Emergency consultation and hospital readmission |
1 and 3 months
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Health Related Quality of Life
기간: 1 and 3 months
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Survey of health related quality of life |
1 and 3 months
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Cost of care at 3 months
기간: 3 months
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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
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Oxygenation data (% of time in the SpO2 target, % of time with hypoxemia, % of time with hyperoxia)
기간: From inclusion to hospital discharge and from hospital discharge to the end of oxygen therapy (around one week after discharge)
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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
기간: 3 months
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Number of consultation : phone call, video consultation, rehabilitation, home visit |
3 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: François Lellouche, Laval University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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