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

Chronic Diseases Clinical Trial

— UTIR  

Official title:

Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577927
• Other study ID #: UTIR
• Secondary ID: Dlg. 5685 on 28
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: June 4, 2014
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: June 2014
• Source: Fondazione Salvatore Maugeri
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Diseases

Intervention

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

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.

Locations

Country	Name	City	State
Italy	Fondazione Salvatore Maugeri	Lumezzane	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Salvatore Maugeri

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)	Respiratory Functionality	Changes from baseline and 4 weeks (average time), and 6 months after home activity	No
Secondary	MRF 26	Quality of life evaluation.	Changes between discharge at 4 weeks (average time) and 6 months after home activity	No
Secondary	Likert Scale	Satisfaction for patient/caregiver	Changes between discharge at 4 weeks (average time) and 6 months after home activity	No
Secondary	Mortality	Clinical measure	Changes between 3, 6 and 12 months post-discharge	No
Secondary	MRC Scale and/or dynamometer	Rehabilitative measure referring to muscles force	Changes between baseline, discharge at 4 weeks, and 6 months after home activity	No
Secondary	6-min walking test	Rehabilitative measure evaluating the effort tolerance.	Changes from baseline and discharge at 4 weeks, and 6 months after home activity	No
Secondary	EuroQol	Quality of life evaluation	Changes between discharge at 4 weeks (average time) and 6 months after home activity	No
Secondary	Gussago Nursing Scale	Measure of dependency.	Changes from baseline and 4 weeks, and 6 months after home activity	No
Secondary	Barthel Index	Measure of dependency.	Changes from baseline and 4 weeks, and 6 months after home activity	No
Secondary	Pre-morbidity life-style (PLS)	Measure of dependency.	Changes from baseline and 4 weeks, and 6 months after home activity	No