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

NCT01577927 | Completed DMC

• 2 other identifiers: UTIRDlg. 5685 on 28 May 2010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Diseases

Keywords

weaning; severe chronic diseases; UTIR

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)

  Changes from baseline and 4 weeks (average time), and 6 months after home activity

• MRF 26

  Changes between discharge at 4 weeks (average time) and 6 months after home activity

• Likert Scale

  Changes between discharge at 4 weeks (average time) and 6 months after home activity

• Mortality

  Changes between 3, 6 and 12 months post-discharge

• MRC Scale and/or dynamometer

  Changes between baseline, discharge at 4 weeks, and 6 months after home activity

Study Arms (2)

Usual home care

ACTIVE COMPARATOR

No assistance or care by PT.

Other: Usual home care

PT-assisted home rehabilitation

EXPERIMENTAL

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

Interventions

Usual home care OTHER

Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.

Usual home care

PT-assisted home rehabilitation BEHAVIORAL

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.

PT-assisted home rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

Study Sites (1)

Fondazione Salvatore Maugeri

Lumezzane, Brescia, 25065, Italy

Location

Related Publications (1)

• 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.

  PMID: 26829083 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Piero Ceriana, MD

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

• Michele Vitacca, MD

  Fondazione Salvatore Maugeri

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 16, 2012
• Study Start: July 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 5, 2014

Record last verified: 2014-06

Locations

IT (1)