Public Health Impact of Unilateral Spatial Neglect
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change in the Health-Related Quality of Life (EQ-5D-5L)
研究概览
简要总结
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 (€).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Other brain disorders
结局指标
主要结局
Change in the Health-Related Quality of Life (EQ-5D-5L)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点