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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Brescia
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Lumezzane、Brescia、イタリア、25065
- Fondazione Salvatore Maugeri
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Critical Patients Autonomy Planning (CPAP)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Piero Ceriana, MD、Fondazione Salvatore Maugeri
- スタディディレクター：Michele Vitacca, MD、Fondazione Salvatore Maugeri
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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