Public Health Impact of Unilateral Spatial Neglect

NCT05792969 | Unknown

• 1 other identifier: 25C123
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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 (€).

Conditions

Spatial Neglect

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

Stroke patients with USN and their caregivers

Behavioral: Functional measures and public health outcomes

Stroke patients without USN and their caregivers

Behavioral: Functional measures and public health outcomes

Interventions

Functional measures and public health outcomes BEHAVIORAL

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 with USN and their caregivers; Stroke patients without USN and their caregivers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients with and without USN and their caregivers

You may qualify if:

• 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).

You may not qualify if:

• Other brain disorders

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, Lombardy, 20122, Italy

RECRUITING

Central Study Contacts

Nadia Bolognini, PhD

CONTACT

+39025821; n.bolognini@auxologico.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 31, 2023
• Study Start: February 7, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

IT (1)