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

Chronic Diseases Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

• NCT number: NCT01577927
• Study type: Interventional
• Source: Fondazione Salvatore Maugeri
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Completion date: July 2013