Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients (UTIR)
|ClinicalTrials.gov Identifier: NCT01577927|
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : June 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Diseases||Other: Usual home care Behavioral: PT-assisted home rehabilitation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||July 2013|
Active Comparator: Usual home care
No assistance or care by PT.
Other: Usual home care
Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.
Experimental: 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.
Behavioral: PT-assisted home rehabilitation
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.
- Critical Patients Autonomy Planning (CPAP) [ Time Frame: Changes from baseline and 4 weeks, and 6 months after home activity ]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.
- Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) [ Time Frame: Changes from baseline and 4 weeks (average time), and 6 months after home activity ]Respiratory Functionality
- MRF 26 [ Time Frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity ]Quality of life evaluation.
- Likert Scale [ Time Frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity ]Satisfaction for patient/caregiver
- Mortality [ Time Frame: Changes between 3, 6 and 12 months post-discharge ]Clinical measure
- MRC Scale and/or dynamometer [ Time Frame: Changes between baseline, discharge at 4 weeks, and 6 months after home activity ]Rehabilitative measure referring to muscles force
- 6-min walking test [ Time Frame: Changes from baseline and discharge at 4 weeks, and 6 months after home activity ]Rehabilitative measure evaluating the effort tolerance.
- EuroQol [ Time Frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity ]Quality of life evaluation
- Gussago Nursing Scale [ Time Frame: Changes from baseline and 4 weeks, and 6 months after home activity ]Measure of dependency.
- Barthel Index [ Time Frame: Changes from baseline and 4 weeks, and 6 months after home activity ]Measure of dependency.
- Pre-morbidity life-style (PLS) [ Time Frame: Changes from baseline and 4 weeks, and 6 months after home activity ]Measure of dependency.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01577927
|Fondazione Salvatore Maugeri|
|Lumezzane, Brescia, Italy, 25065|
|Principal Investigator:||Piero Ceriana, MD||Fondazione Salvatore Maugeri|
|Study Director:||Michele Vitacca, MD||Fondazione Salvatore Maugeri|