Public Health Impact of Unilateral Spatial Neglect

Recruiting

• Conditions: Spatial Neglect
• Interventions: Behavioral: Functional measures and public health outcomes

• Registration Number: NCT05792969
• Lead Sponsor: Istituto Auxologico Italiano

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 (€).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-07
• Status Verified: 2023-03
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Study First Posted: 2023-03-31
• Last Update Posted: 2023-03-31
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients without USN and their caregivers	Functional measures and public health outcomes	-
Stroke patients with USN and their caregivers	Functional measures and public health outcomes	-

Primary Outcome Measures

Name	Time	Method
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 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
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)
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 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
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.

Trial Locations

Locations (1)

Istituto Auxologico Italiano IRCCS; 🇮🇹 Milan, Lombardia, Italy