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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michele Vitacca, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier:
NCT01577927
First received: April 10, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Chronic Diseases
Other: Usual home care
Behavioral: PT-assisted home rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit

Resource links provided by NLM:


Further study details as provided by Fondazione Salvatore Maugeri:

Primary Outcome Measures:
  • Critical Patients Autonomy Planning (CPAP) [ Time Frame: Changes from baseline and 4 weeks, and 6 months after home activity ] [ Designated as safety issue: No ]
    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:
  • Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) [ Time Frame: Changes from baseline and 4 weeks (average time), and 6 months after home activity ] [ Designated as safety issue: No ]
    Respiratory Functionality

  • MRF 26 [ Time Frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity ] [ Designated as safety issue: No ]
    Quality of life evaluation.

  • Likert Scale [ Time Frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity ] [ Designated as safety issue: No ]
    Satisfaction for patient/caregiver

  • Mortality [ Time Frame: Changes between 3, 6 and 12 months post-discharge ] [ Designated as safety issue: No ]
    Clinical measure

  • MRC Scale and/or dynamometer [ Time Frame: Changes between baseline, discharge at 4 weeks, and 6 months after home activity ] [ Designated as safety issue: No ]
    Rehabilitative measure referring to muscles force

  • 6-min walking test [ Time Frame: Changes from baseline and discharge at 4 weeks, and 6 months after home activity ] [ Designated as safety issue: No ]
    Rehabilitative measure evaluating the effort tolerance.

  • EuroQol [ Time Frame: Changes between discharge at 4 weeks (average time) and 6 months after home activity ] [ Designated as safety issue: No ]
    Quality of life evaluation

  • Gussago Nursing Scale [ Time Frame: Changes from baseline and 4 weeks, and 6 months after home activity ] [ Designated as safety issue: No ]
    Measure of dependency.

  • Barthel Index [ Time Frame: Changes from baseline and 4 weeks, and 6 months after home activity ] [ Designated as safety issue: No ]
    Measure of dependency.

  • Pre-morbidity life-style (PLS) [ Time Frame: Changes from baseline and 4 weeks, and 6 months after home activity ] [ Designated as safety issue: No ]
    Measure of dependency.


Enrollment: 60
Study Start Date: July 2011
Study Completion Date: July 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577927

Locations
Italy
Fondazione Salvatore Maugeri
Lumezzane, Brescia, Italy, 25065
Sponsors and Collaborators
Fondazione Salvatore Maugeri
Investigators
Principal Investigator: Piero Ceriana, MD Fondazione Salvatore Maugeri
Study Director: Michele Vitacca, MD Fondazione Salvatore Maugeri
  More Information

No publications provided

Responsible Party: Michele Vitacca, Principal investigator, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT01577927     History of Changes
Other Study ID Numbers: UTIR, Dlg. 5685 on 28 May 2010
Study First Received: April 10, 2012
Last Updated: June 4, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Salvatore Maugeri:
weaning
severe chronic diseases
UTIR

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014