Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients (UTIR)
Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit
Patients at high complexity with severe chronic diseases can require several admission in intensive care units (ICU) to overcome acute exacerbations by the use of assisted ventilation. In the last 10 years, new technologies and beds in ICU evidenced a new group of patients often needing weaning procedures due to a long-lasting period of mechanical ventilation. These patients are often under chronic conditions with recurrent symptoms, reduced effort tolerance and depression.
Weaning process is a frail step in the medical history of a patient who has survived an acute episode of respiratory failure and has spent a period of time under mechanical ventilation. Patients are followed for the duration of in-hospital stay, an expected average period of 4 weeks.
When discharged fron an Intensive Care Unit (ICU) or a weaning center, the patient is usually managed by GPs and by the hospital where he has been admitted to following re-exacerbations. The conventional approach is for sure inadequate for this type of patient whose clinical complexity, disability and frailty need for a continuity of care through a higher complex approach of management.
A structured program of Home Rehabilitation could be a possible solution to this problem. Thus, the hypothesis of the study is to evaluate feasibility and sustainability and efficacy of a home rehabilitative network for prolonged weaned patients discharged from a weaning unit.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Brescia
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Lumezzane, Brescia, 이탈리아, 25065
- Fondazione Salvatore Maugeri
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
- General Inclusion criteria: 1. Signature of the informed 2. Good expectation of life
- Specific Inclusion Criteria : Score of general dependences < 19 according to the Critical Patients Autonomy Planning (CPAP) Scale
Exclusion Criteria:
- Patient with neuromuscular, highly progressive neurological diseases (i.e. amyotrophic lateral sclerosis), patient requiring surgical interventions, sedation, and hemodialysis.
- Unstable patient conditions as daily variability of the blood arterial pressure >20%, arrhythmias, PaO2/FiO2 < 300, unsatisfactory respiratory pattern, haemoglobin < 7 g /dL, temperature > 38°C, presence of neurological or orthopaedic side effects, and recent embolisms from TVP. Refusal.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Usual home care
No assistance or care by PT.
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Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.
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실험적: PT-assisted home rehabilitation
Assisted home care is supported by a PT at least 2 times/month.
Few brief educational lessons preceeded the training activity that the patient performs by himself at home.
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Patient performs 50 min physical activity/working day autonomously by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles. Every two weeks, PT phones the patient for an educational reinforcement. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Critical Patients Autonomy Planning (CPAP)
기간: Changes from baseline and 4 weeks, and 6 months after home activity
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CPAP is a measure of dependency.
CPAP was evaluated at three different time-points: at in-hospital admission (baseline), at discharge (patients are followed for the duration of their in-hospital stay, an expected average time of 4 weeks), and after 6 months of physical activity at home.
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Changes from baseline and 4 weeks, and 6 months after home activity
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
기간: Changes from baseline and 4 weeks (average time), and 6 months after home activity
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Respiratory Functionality
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Changes from baseline and 4 weeks (average time), and 6 months after home activity
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MRF 26
기간: Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Quality of life evaluation.
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Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Likert Scale
기간: Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Satisfaction for patient/caregiver
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Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Mortality
기간: Changes between 3, 6 and 12 months post-discharge
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Clinical measure
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Changes between 3, 6 and 12 months post-discharge
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MRC Scale and/or dynamometer
기간: Changes between baseline, discharge at 4 weeks, and 6 months after home activity
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Rehabilitative measure referring to muscles force
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Changes between baseline, discharge at 4 weeks, and 6 months after home activity
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6-min walking test
기간: Changes from baseline and discharge at 4 weeks, and 6 months after home activity
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Rehabilitative measure evaluating the effort tolerance.
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Changes from baseline and discharge at 4 weeks, and 6 months after home activity
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EuroQol
기간: Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Quality of life evaluation
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Changes between discharge at 4 weeks (average time) and 6 months after home activity
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Gussago Nursing Scale
기간: Changes from baseline and 4 weeks, and 6 months after home activity
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Measure of dependency.
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Changes from baseline and 4 weeks, and 6 months after home activity
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Barthel Index
기간: Changes from baseline and 4 weeks, and 6 months after home activity
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Measure of dependency.
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Changes from baseline and 4 weeks, and 6 months after home activity
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Pre-morbidity life-style (PLS)
기간: Changes from baseline and 4 weeks, and 6 months after home activity
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Measure of dependency.
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Changes from baseline and 4 weeks, and 6 months after home activity
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공동 작업자 및 조사자
수사관
- 수석 연구원: Piero Ceriana, MD, Fondazione Salvatore Maugeri
- 연구 책임자: Michele Vitacca, MD, Fondazione Salvatore Maugeri
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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