Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Patients referred to the Fondazione Salvatore Maugeri for prolonged weaning are enrolled and trained in an individualised program of home care in order to recover their own autonomies. Home care compares 2 arms: usual care vs physiotherapist (PT)-assisted care. Usual care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance, periodical in-hospital visit. The PT-assisted home care is supported by PT at least 2 times/month, autonomous 50 min physical activity/working day by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles. Few brief educational lessons by PT preceded the training activity. Every two weeks, PT calls the patient by phone for an educational reinforcement.

Official Title
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Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit

Conditions
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Chronic Diseases

Intervention / Treatment
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* Other: Usual home care
* Behavioral: PT-assisted home rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual home care<br>No assistance or care by PT. | Other: Usual home care<br>* Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.<br>|
| Experimental: PT-assisted home rehabilitation<br>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. | Behavioral: PT-assisted home rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Critical Patients Autonomy Planning (CPAP) | 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. | Changes from baseline and 4 weeks, and 6 months after home activity | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) | Respiratory Functionality | Changes from baseline and 4 weeks (average time), and 6 months after home activity | 
| MRF 26 | Quality of life evaluation. | Changes between discharge at 4 weeks (average time) and 6 months after home activity | 
| Likert Scale | Satisfaction for patient/caregiver | Changes between discharge at 4 weeks (average time) and 6 months after home activity | 
| Mortality | Clinical measure | Changes between 3, 6 and 12 months post-discharge | 
| MRC Scale and/or dynamometer | Rehabilitative measure referring to muscles force | Changes between baseline, discharge at 4 weeks, and 6 months after home activity | 
| 6-min walking test | Rehabilitative measure evaluating the effort tolerance. | Changes from baseline and discharge at 4 weeks, and 6 months after home activity | 
| EuroQol | Quality of life evaluation | Changes between discharge at 4 weeks (average time) and 6 months after home activity | 
| Gussago Nursing Scale | Measure of dependency. | Changes from baseline and 4 weeks, and 6 months after home activity | 
| Barthel Index | Measure of dependency. | Changes from baseline and 4 weeks, and 6 months after home activity | 
| Pre-morbidity life-style (PLS) | Measure of dependency. | Changes from baseline and 4 weeks, and 6 months after home activity | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weaning, severe chronic diseases, UTIR