Public Health Impact of Unilateral Spatial Neglect

Spatial Neglect Clinical Trial

— IMPAssNEGLECT  

Official title:

Public Health Impact of Unilateral Spatial Neglect

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792969
• Other study ID #: 25C123
• Status: Recruiting
• Start date: February 7, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Nadia Bolognini, PhD
• Phone: +39025821
• Email: n.bolognini[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 (€).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Perceptual Disorders
• Spatial Neglect

Intervention

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)

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano IRCCS	Milan	Lombardia

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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