Clinical trial NCT01577927: Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients
Official title: Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Diseases
Keywords: weaning
severe chronic diseases
UTIR
Lead sponsor: Fondazione Salvatore Maugeri
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Critical Patients Autonomy Planning (CPAP)
timeFrame: Changes from baseline and 4 weeks, and 6 months after home activity
Secondary outcomes:
measure: Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
timeFrame: Changes from baseline and 4 weeks (average time), and 6 months after home activity
measure: MRF 26
timeFrame: Changes between discharge at 4 weeks (average time) and 6 months after home activity
measure: Likert Scale
timeFrame: Changes between discharge at 4 weeks (average time) and 6 months after home activity
measure: Mortality
timeFrame: Changes between 3, 6 and 12 months post-discharge
measure: MRC Scale and/or dynamometer
timeFrame: Changes between baseline, discharge at 4 weeks, and 6 months after home activity
measure: 6-min walking test
timeFrame: Changes from baseline and discharge at 4 weeks, and 6 months after home activity
measure: EuroQol
timeFrame: Changes between discharge at 4 weeks (average time) and 6 months after home activity
measure: Gussago Nursing Scale
timeFrame: Changes from baseline and 4 weeks, and 6 months after home activity
measure: Barthel Index
timeFrame: Changes from baseline and 4 weeks, and 6 months after home activity
measure: Pre-morbidity life-style (PLS)
timeFrame: Changes from baseline and 4 weeks, and 6 months after home activity
Other outcomes:
Locations:
city: Lumezzane
country: Italy
facility: Fondazione Salvatore Maugeri
state: Brescia
Study officials:
affiliation: Fondazione Salvatore Maugeri
name: Piero Ceriana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione Salvatore Maugeri
name: Michele Vitacca, MD
role: STUDY_DIRECTOR
References:
citation: 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.