Public Health Impact of Unilateral Spatial Neglect (IMPAssNEGLECT)

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 (€).

Study Overview

• Status: Recruiting
• Conditions: Spatial Neglect
• Intervention / Treatment: Behavioral: Functional measures and public health outcomes

• Study Type: Observational
• Enrollment (Anticipated): 168

Contacts and Locations

• Study Contact: Name: Nadia Bolognini, PhD; Phone Number: 8132 +39025821; Email: n.bolognini@auxologico.it

Study Locations

• Italy
  • Lombardia
    • Milan, Lombardia, Italy, 20122
      • Recruiting
      • Istituto Auxologico Italiano IRCCS
      • Contact: Nadia Bolognini, PhD; Phone Number: 8132 +39025821; Email: n.bolognini@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stroke patients with and without USN and their caregivers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Anticipated): November 30, 2024
• Study Completion (Anticipated): November 30, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders
• Other Study ID Numbers: 25C123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No