Clinical trial NCT05792969: Public Health Impact of Unilateral Spatial Neglect
Official title: Public Health Impact of Unilateral Spatial Neglect
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spatial Neglect
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patients with and without USN and their caregivers

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 (€).


Eligibility 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

Primary outcomes:
measure: Change in the Activities of Daily Living scale (ADL)
timeFrame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
measure: Change in the Instrumental Activities of Daily Living scale (I-ADL)
timeFrame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
measure: Change in the Health-Related Quality of Life (EQ-5D-5L)
timeFrame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
measure: Change in the Geriatric Depression Scale (GDS)
timeFrame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
measure: Change in the State-Trait Anxiety Inventory (STAI-Y)
timeFrame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
measure: Change in the Caregiver Burden Inventory questionnaire (CBI)
timeFrame: At baseline (at the beginning of the treatment) and after 1, 3, 6, and 12 months after the end of the treatment
measure: Financial impact of USN
timeFrame: 1 month after the end of the treatment
measure: Financial impact of USN
timeFrame: 3 months after the end of the treatment
measure: Financial impact of USN
timeFrame: 6 months after the end of the treatment
measure: Financial impact of USN
timeFrame: 12 months after the end of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
state: Lombardia
Study officials:
References: