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

Not Applicable

Completed

• Conditions: Chronic Diseases
• Interventions: Other: Usual home care; Behavioral: PT-assisted home rehabilitation

• Registration Number: NCT01577927
• Lead Sponsor: Fondazione Salvatore Maugeri

Brief 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.

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Primary Completion: 2013-01
• Study Completion: 2013-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-04
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual home care	Usual home care	No assistance or care by PT.
PT-assisted home rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Critical Patients Autonomy Planning (CPAP)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Salvatore Maugeri; 🇮🇹 Lumezzane, Brescia, Italy