IMPAssNEGLECT: Public Health Impact of Unilateral Spatial Neglect
Study Details
Study Description
Brief Summary
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 (€).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Stroke patients with USN and their caregivers
|
Behavioral: 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
|
Behavioral: 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)
|
Outcome Measures
Primary Outcome Measures
- Change in the Activities of Daily Living scale (ADL) [At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment]
To evaluate the degree of patients' functional independence in everyday life
- Change in the Instrumental Activities of Daily Living scale (I-ADL) [At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment]
To evaluate the degree of patients' functional independence instrumental activities, including, e.g., cleaning, cooking, and managing finances.
- Change in the Health-Related Quality of Life (EQ-5D-5L) [At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment]
A brief scale assessing patient's health-related quality of life
- Change in the Geriatric Depression Scale (GDS) [At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment]
A scale assessing patients' depressive symptoms
- Change in the State-Trait Anxiety Inventory (STAI-Y) [At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment]
A scale assessing patients' anxiety symptoms
- Change in the Caregiver Burden Inventory questionnaire (CBI) [At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment]
A scale that assess caregivers' physical and psychological burden
- Financial impact of USN [1 month after the end of the treatment]
A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves)
- Financial impact of USN [3 months after the end of the treatment]
A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves)
- Financial impact of USN [6 months after the end of the treatment]
A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves)
- Financial impact of USN [12 months after the end of the treatment]
A questionnaire about health-related costs associated to the disease (e.g., heath examinations, medicines, sick leaves)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Auxologico Italiano IRCCS | Milan | Lombardia | Italy | 20122 |
Sponsors and Collaborators
- Istituto Auxologico Italiano
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 25C123