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.

Study Overview

• Status: Completed
• Conditions: Chronic Diseases
• Intervention / Treatment: Other: Usual home care; Behavioral: PT-assisted home rehabilitation

Detailed 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Brescia
    • Lumezzane, Brescia, Italy, 25065
      • Fondazione Salvatore Maugeri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondazione Salvatore Maugeri
• Investigators: Principal Investigator: Piero Ceriana, MD, Fondazione Salvatore Maugeri; Study Director: Michele Vitacca, MD, Fondazione Salvatore Maugeri

Publications and helpful links

General Publications

• Vitacca M, Barbano L, Vanoglio F, Luisa A, Bernocchi P, Giordano A, Paneroni M. Does 6-Month Home Caregiver-Supervised Physiotherapy Improve Post-Critical Care Outcomes?: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2016 Aug;95(8):571-9. doi: 10.1097/PHM.0000000000000441.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 13, 2012
• First Posted (Estimate): April 16, 2012

Study Record Updates

• Last Update Posted (Estimate): June 5, 2014
• Last Update Submitted That Met QC Criteria: June 4, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: weaning; severe chronic diseases; UTIR
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: UTIR; Dlg. 5685 on 28 May 2010 (Other Grant/Funding Number: Lombardy Region)