Factors Affecting the Quality of Life After Ischemic Stroke in Young Adults: a Prospective Observational Study in Young Ischemic Stroke Patients Under 50 Years
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Change in the Stroke Impact Scale (version 3.0)
研究概览
简要总结
Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Better identification and understanding to these factors may improve stroke rehabilitation and stroke self-management programmes, wich will lead to better stroke recovery. The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. In the second phase of study, 200 enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In the third phase of study, twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used.
详细描述
Despite a generally favourable 3-month functional outcome and a very low mortality, young ischemic stroke (IS) patients face to reduced quality of life associated with a complexity of problems or "invisible dysfunctions" after IS. Fatigue, cognitive impairment, anxiety, depression, sexual dysfunction, loss of employment, social isolation, lack of specialist support, reduction in mobility and life roles, negative body image, impaired self-efficacy and self-esteem are considered most relevant factors. Investigation of predictors of post-stroke quality of life in young-onset patients is needed to design, implement, and evaluate specific young stroke rehabilitation and stroke self-management programmes.
The aim of the study is to assess the predictors of the health-related quality of life in young patients under 50 years after ischemic stroke, and to evaluate specific changes in different dimensions of health-related quality of life during the first year of post-stroke recovery using a standardized battery of neuropsychological tools and stroke specific health-related quality of life measures. The aims of the study will be met by the triangulation of qualitative and quantitative research methods.
In the first phase of the study, 300 IS patients will be enrolled for the validation of the Czech version of the the Stroke Impact Scale 3.0. The reliability and validity study will have a cross-sectional design. In the second phase of study, 200 enrolled IS patients (100 young IS patients < 50 years and 100 IS patients of 50-65 years) will undergo a serial of structured and standardized questionnaires during scheduled outpatients' controls three, six and 12 months after IS. In all enrolled patients, the functional outcome, neuropsychological status and quality of life will be assessed using standardized scales and tools. In the third phase of study, twenty young IS patients < 50 years will undergo an in-depth, semi-structured interview with explanatory questions that will allow a detailed understanding of the patient's experience. Interpretative phenomenological analysis (IPA) study design will be used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke
- •Age 18-65 years
排除标准
- •Transient ischemic attack without progression to ischemic stroke
- •Haemorrhagic stroke
- •Severe cognitive impairment
- •Severe communication disorder (sensory aphasia with the inability to understand having been verified by a certified speech therapist)
- •Concomitant severe systemic illness
- •Impaired ability to understand the questionnaires
结局指标
主要结局
Change in the Stroke Impact Scale (version 3.0)
时间窗: three, six and 12 months after stroke
Assessment of the impact of stroke on eight domains relating to self-rated quality of life, self-perceived disability, and global recovery after stroke (i.e., strength, hand function, mobility, physical and instrumental activities of daily living, memory and thinking, communication, emotion, and social participation). Scores for each domain range from 0 to 100, and higher scores indicate a better health related quality of life
次要结局
- Change of post-stroke depression and anxiety (self-reported)(three, six and 12 months after stroke)
- Change of the World Health Organization Quality of Life - BREF version (WHOQOL-BREF, self-reported)(three, six and 12 months after stroke)
- Change of the Barthel Index of Activities of Daily Living (self-reported)(three, six and 12 months after stroke)
- Change of Modified Rankin Scale (self-reported)(three, six and 12 months after stroke)
- Change of the Montreal Cognitive Assessment (MoCA)(three, six and 12 months after stroke)
- Change from 3-month the lived experience of ischemic stroke of young patients up to 50 years at 12 months.(three and 12 months after stroke)
- Change in the NIH Stroke Scale (NIHSS)(three, six and 12 months after stroke)
研究者
Elena Gurkova
Associated professor
Palacky University