The Relationship Between Trajectories of Post-stroke Disability and Self-rated Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Change of self-rated health
研究概览
简要总结
Stroke is thought to cause disability immediately after stroke followed by a 3-to-6-month recovery period, after which disability levels are supposed to stabilize unless recurrent events occur. However, studies showed that post-stroke recovery is heterogeneous. While some stroke survivors quickly recover, others may show an accelerated accumulation of disability over time. The current prospective observational study will investigate trajectories of multidimensional functioning and self-rated health in the year after stroke. Particularly, the study aims to explore the relationship between trajectories of disability and self-rated health. Moreover, the study will focus on potential predictors of changes in disability and self-rated health, i.e., views on aging and psychological resilience. Patients will be recruited during their stay at the stroke unit and participate in a face-to-face interview and four follow-up telephone interviews in the post-stroke year.
详细描述
Ischemic strokes have shown to have long-term impact on functional health apart from their acute effects on neurological functioning. Stroke survivors may experience long-term physical disability, psychopathological symptoms and cognitive decline. Even though these potential consequences are well studied, knowledge on post-stroke trajectories of multidimensional functional health according to the Word Health Organization's (WHO) International Classification of Functioning, Disability and Health (ICF) and their predictors is rare. Particularly, there is a lack of studies investigating the trajectories of self-rated health and different indicators of functional health in the year post-stroke. Therefore, the current study aims to explore trajectories of disability and self-rated health in the year post-stroke, and is the first to analyze the relationship between these trajectories. Thereby, the study addresses the research question whether changes in disability can be predicted by prior self-rated health or changes of self-rated health, and vice versa. Moreover, the study examines the correspondence between changes of disability and self-rated health in the year post-stroke. Additionally, views on aging and psychological resilience, which are relevant to coping processes, are studied as predictors of changes in disability and self-rated health. Patients recruited during their stay at the stroke unit will participate in one face-to-face interview in hospital and four telephone follow-up interviews at 6 weeks, 3 months, 6 months and 12 months post-stroke. Moreover, physical functioning will be externally assessed during their hospital stay. To increase the knowledge on post-stroke trajectories of multidimensional health is of major importance to identify patients at risk for accelerated accumulation of disability. Findings from the current study may contribute to the improvement of post-stroke rehabilitation and secondary prevention.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Acute ischemic stroke/high-risk transient ischemic attack (TIA; ABCD2 score ≥ 3)
- •Language: Fluent in German
- •Written informed consent of patient or caregiver
排除标准
- •Low-risk TIA (ABCD2 score ≤ 2)
- •Severe cognitive impairment (i.e., incomplete orientation)
- •Severe communication disorder
- •Index event > 5 days prior to enrolment
- •Life expectancy < 1 year
结局指标
主要结局
Change of self-rated health
时间窗: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
1-Item assessment of self-rated health
Change of Modified Rankin Scale (self-reported)
时间窗: 1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke
Degree of disability and dependency
次要结局
- Change of Fatigue Severity Scale(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of Post-Traumatic Stress Syndrome 14 (assessment in case of sufficient capacities)(6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of Questions on Falling(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of Impact of Stroke Scale 16(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of Patient Health Questionnaire-8(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of Barthel Index (self-reported)(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of European Health Interview Survey Physical Activity Questionnaire(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of IMET (Index for the Assessment of Participation Restrictions)(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
- Change of Pittsburgh Sleep Quality Index (assessment in case of sufficient capacities)(1-5 days post-stroke, 6 weeks post-stroke, 3 months post-stroke, 6 months post-stroke, 12 months post-stroke)
研究者
Susanne Wurm
Principal Investigator, Head of Prevention Research and Social Medicine
University Medicine Greifswald