Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT01577927
Status:
COMPLETED
Last Update Posted:
2014-06-05
First Post:
2012-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002908', 'term': 'Chronic Disease'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-04', 'studyFirstSubmitDate': '2012-04-10', 'studyFirstSubmitQcDate': '2012-04-13', 'lastUpdatePostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Critical Patients Autonomy Planning (CPAP)', 'timeFrame': 'Changes from baseline and 4 weeks, and 6 months after home activity', '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.'}], 'secondaryOutcomes': [{'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', 'description': 'Respiratory Functionality'}, {'measure': 'MRF 26', 'timeFrame': 'Changes between discharge at 4 weeks (average time) and 6 months after home activity', 'description': 'Quality of life evaluation.'}, {'measure': 'Likert Scale', 'timeFrame': 'Changes between discharge at 4 weeks (average time) and 6 months after home activity', 'description': 'Satisfaction for patient/caregiver'}, {'measure': 'Mortality', 'timeFrame': 'Changes between 3, 6 and 12 months post-discharge', 'description': 'Clinical measure'}, {'measure': 'MRC Scale and/or dynamometer', 'timeFrame': 'Changes between baseline, discharge at 4 weeks, and 6 months after home activity', 'description': 'Rehabilitative measure referring to muscles force'}, {'measure': '6-min walking test', 'timeFrame': 'Changes from baseline and discharge at 4 weeks, and 6 months after home activity', 'description': 'Rehabilitative measure evaluating the effort tolerance.'}, {'measure': 'EuroQol', 'timeFrame': 'Changes between discharge at 4 weeks (average time) and 6 months after home activity', 'description': 'Quality of life evaluation'}, {'measure': 'Gussago Nursing Scale', 'timeFrame': 'Changes from baseline and 4 weeks, and 6 months after home activity', 'description': 'Measure of dependency.'}, {'measure': 'Barthel Index', 'timeFrame': 'Changes from baseline and 4 weeks, and 6 months after home activity', 'description': 'Measure of dependency.'}, {'measure': 'Pre-morbidity life-style (PLS)', 'timeFrame': 'Changes from baseline and 4 weeks, and 6 months after home activity', 'description': 'Measure of dependency.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['weaning', 'severe chronic diseases', 'UTIR'], 'conditions': ['Chronic Diseases']}, 'referencesModule': {'references': [{'pmid': '26829083', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nWeaning 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.\n\nWhen 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.\n\nA 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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* General Inclusion criteria: 1. Signature of the informed 2. Good expectation of life\n* Specific Inclusion Criteria : Score of general dependences \\< 19 according to the Critical Patients Autonomy Planning (CPAP) Scale\n\nExclusion Criteria:\n\n* Patient with neuromuscular, highly progressive neurological diseases (i.e. amyotrophic lateral sclerosis), patient requiring surgical interventions, sedation, and hemodialysis.\n* 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.'}, 'identificationModule': {'nctId': 'NCT01577927', 'acronym': 'UTIR', 'briefTitle': 'Feasibility Study of a Home Rehabilitative Network to Treat Prolonged Weaned Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Salvatore Maugeri'}, 'officialTitle': 'Feasibility and Efficacy of a Home Rehabilitative Network for Prolonged Weaned Patients Discharged From a Weaning Unit', 'orgStudyIdInfo': {'id': 'UTIR'}, 'secondaryIdInfos': [{'id': 'Dlg. 5685 on 28 May 2010', 'type': 'OTHER_GRANT', 'domain': 'Lombardy Region'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual home care', 'description': 'No assistance or care by PT.', 'interventionNames': ['Other: Usual home care']}, {'type': 'EXPERIMENTAL', 'label': 'PT-assisted home rehabilitation', '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.', 'interventionNames': ['Behavioral: PT-assisted home rehabilitation']}], 'interventions': [{'name': 'Usual home care', 'type': 'OTHER', 'description': "Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.", 'armGroupLabels': ['Usual home care']}, {'name': 'PT-assisted home rehabilitation', 'type': 'BEHAVIORAL', '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.\n\nEvery two weeks, PT phones the patient for an educational reinforcement.', 'armGroupLabels': ['PT-assisted home rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25065', 'city': 'Lumezzane', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Fondazione Salvatore Maugeri', 'geoPoint': {'lat': 45.64789, 'lon': 10.26487}}], 'overallOfficials': [{'name': 'Piero Ceriana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Salvatore Maugeri'}, {'name': 'Michele Vitacca, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fondazione Salvatore Maugeri'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Salvatore Maugeri', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Michele Vitacca', 'investigatorAffiliation': 'Fondazione Salvatore Maugeri'}}}}