Public Health Impact of Unilateral Spatial Neglect

Study Overview
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Brief Summary
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This multi-center project aims to quantify the socio-medical costs associated with Unilateral Spatial Neglect (USN) resulting from acquired brain injury (stroke) and to measure the effects of USN rehabilitation on functional autonomy, quality of life and psychological well-being of patients affected by this syndrome, considering the repercussions on a psychological level and on the quality of life of caregivers. 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 (€).

Official Title
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Public Health Impact of Unilateral Spatial Neglect

Conditions
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Spatial Neglect

Intervention / Treatment
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* Behavioral: Functional measures and public health outcomes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 18 years; 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: Other brain disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke patients with USN and their caregivers<br> | Behavioral: Functional measures and public health outcomes<br>* 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)<br>|
| Stroke patients without USN and their caregivers<br> | Behavioral: Functional measures and public health outcomes<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Activities of Daily Living scale (ADL) | To evaluate the degree of patients' functional independence in everyday life | At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment | 
| Change in the Instrumental Activities of Daily Living scale (I-ADL) | To evaluate the degree of patients' functional independence instrumental activities, including, e.g., cleaning, cooking, and managing finances. | At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment | 
| Change in the Health-Related Quality of Life (EQ-5D-5L) | A brief scale assessing patient's health-related quality of life | At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment | 
| Change in the Geriatric Depression Scale (GDS) | A scale assessing patients' depressive symptoms | At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment | 
| Change in the State-Trait Anxiety Inventory (STAI-Y) | A scale assessing patients' anxiety symptoms | At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment | 
| Change in the Caregiver Burden Inventory questionnaire (CBI) | A scale that assess caregivers' physical and psychological burden | At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment | 
| Financial impact of USN | A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves) | 1 month after the end of the treatment | 
| Financial impact of USN | A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves) | 3 months after the end of the treatment | 
| Financial impact of USN | A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves) | 6 months after the end of the treatment | 
| Financial impact of USN | A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves) | 12 months after the end of the treatment |