Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients (UTIR)
Primary Purpose
Chronic Diseases
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Usual home care
PT-assisted home rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Diseases focused on measuring weaning, severe chronic diseases, UTIR
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.
Sites / Locations
- Fondazione Salvatore Maugeri
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual home care
PT-assisted home rehabilitation
Arm Description
No assistance or care by PT.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Respiratory Functionality
MRF 26
Quality of life evaluation.
Likert Scale
Satisfaction for patient/caregiver
Mortality
Clinical measure
MRC Scale and/or dynamometer
Rehabilitative measure referring to muscles force
6-min walking test
Rehabilitative measure evaluating the effort tolerance.
EuroQol
Quality of life evaluation
Gussago Nursing Scale
Measure of dependency.
Barthel Index
Measure of dependency.
Pre-morbidity life-style (PLS)
Measure of dependency.
Full Information
NCT ID
NCT01577927
First Posted
April 10, 2012
Last Updated
June 4, 2014
Sponsor
Fondazione Salvatore Maugeri
1. Study Identification
Unique Protocol Identification Number
NCT01577927
Brief Title
Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients
Acronym
UTIR
Official Title
Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Salvatore Maugeri
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Diseases
Keywords
weaning, severe chronic diseases, UTIR
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual home care
Arm Type
Active Comparator
Arm Description
No assistance or care by PT.
Arm Title
PT-assisted home rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual home care
Intervention Description
Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.
Intervention Type
Behavioral
Intervention Name(s)
PT-assisted home rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Critical Patients Autonomy Planning (CPAP)
Description
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.
Time Frame
Changes from baseline and 4 weeks, and 6 months after home activity
Secondary Outcome Measure Information:
Title
Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)
Description
Respiratory Functionality
Time Frame
Changes from baseline and 4 weeks (average time), and 6 months after home activity
Title
MRF 26
Description
Quality of life evaluation.
Time Frame
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Title
Likert Scale
Description
Satisfaction for patient/caregiver
Time Frame
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Title
Mortality
Description
Clinical measure
Time Frame
Changes between 3, 6 and 12 months post-discharge
Title
MRC Scale and/or dynamometer
Description
Rehabilitative measure referring to muscles force
Time Frame
Changes between baseline, discharge at 4 weeks, and 6 months after home activity
Title
6-min walking test
Description
Rehabilitative measure evaluating the effort tolerance.
Time Frame
Changes from baseline and discharge at 4 weeks, and 6 months after home activity
Title
EuroQol
Description
Quality of life evaluation
Time Frame
Changes between discharge at 4 weeks (average time) and 6 months after home activity
Title
Gussago Nursing Scale
Description
Measure of dependency.
Time Frame
Changes from baseline and 4 weeks, and 6 months after home activity
Title
Barthel Index
Description
Measure of dependency.
Time Frame
Changes from baseline and 4 weeks, and 6 months after home activity
Title
Pre-morbidity life-style (PLS)
Description
Measure of dependency.
Time Frame
Changes from baseline and 4 weeks, and 6 months after home activity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piero Ceriana, MD
Organizational Affiliation
Fondazione Salvatore Maugeri
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michele Vitacca, MD
Organizational Affiliation
Fondazione Salvatore Maugeri
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione Salvatore Maugeri
City
Lumezzane
State/Province
Brescia
ZIP/Postal Code
25065
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
26829083
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.
Results Reference
derived
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Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients
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