Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
168 participants
OBSERVATIONAL
2022-02-07
2024-11-30
Brief Summary
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To this end, the experimenters will administer to right brain-injured patients - with (Experimental Group) or without (Control Group) USN - who undertook a rehabilitation process, a series of questionnaires: Activities of daily living (ADL), Barthel Index; Instrumental activities of daily living scale (I-ADL:), the Health Related Quality of Life questionnaire (EQ-5D-5L), the Geriatric Depression Scale (GDS), and the State-Trait Anxiety Inventory (STAI-Y). The aforementioned tests will be administered before the start of the rehabilitation (baseline) and after one month, 3, 6 and 12 months after the end of the rehabilitation. The impact of USN and its treatment on the psycho-physical well-being of the caregiver will be measured through the Caregiver Burden Inventory questionnaire, which will be administered with the same timing (baseline, 1-3-6-12 months after rehabilitation). The costs of USN will be surveyed through an ad-hoc questionnaire, which includes a version intended for patients and one for caregivers, in order to identify the resources consumed due to the disease and the expenses taken during the observation period, to be estimated subsequently in monetary terms (€).
Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Stroke patients with USN and their caregivers
Functional measures and public health outcomes
Questionnaires:
* Activities of daily living - ADL
* Barthel Index
* Instrumental activities of daily living- IADL
* Health Related Quality of Life - EQ-5D-5L
* Geriatric Depression Scale (GDS)
* State-Trait Anxiety Inventory - STAI-Y)
* Caregiver Burden Inventory questionnaire (CBI)
Stroke patients without USN and their caregivers
Functional measures and public health outcomes
Questionnaires:
* Activities of daily living - ADL
* Barthel Index
* Instrumental activities of daily living- IADL
* Health Related Quality of Life - EQ-5D-5L
* Geriatric Depression Scale (GDS)
* State-Trait Anxiety Inventory - STAI-Y)
* Caregiver Burden Inventory questionnaire (CBI)
Interventions
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Functional measures and public health outcomes
Questionnaires:
* Activities of daily living - ADL
* Barthel Index
* Instrumental activities of daily living- IADL
* Health Related Quality of Life - EQ-5D-5L
* Geriatric Depression Scale (GDS)
* State-Trait Anxiety Inventory - STAI-Y)
* Caregiver Burden Inventory questionnaire (CBI)
Eligibility Criteria
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Inclusion Criteria
* right brain injury due to stroke (of ischemic or hemorrhagic origin);
* Disease duration ≥ 10 days;
* Participation to a rehabilitation program;
For stroke patients with USN:
\- clinical diagnosis of USN, placed by the specialist of reference, on the basis of clinical indicators and the results obtained by the patient in the routine neuropsychological evaluation (by means of a battery of standardized psychometric tests calibrated in the Italian population).
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Locations
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Istituto Auxologico Italiano IRCCS
Milan, Lombardy, Italy
Countries
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Central Contacts
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Facility Contacts
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Nadia Bolognini, PhD
Role: primary
Other Identifiers
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25C123
Identifier Type: -
Identifier Source: org_study_id