Department of Prevention Research and Social Medicine, University Medicine Greifswald, Greifswald, Germany.
Department of Neurology, University Medicine Greifswald, Greifswald, Germany.
BMJ Open. 2021 Jun 29;11(6):e049944. doi: 10.1136/bmjopen-2021-049944.
Stroke is the leading neurological cause of adult long-term disability in Europe. Even though functional consequences directly related to neurological impairment are well studied, post-stroke trajectories of functional health according to the International Classification of Functioning, Disability and Health are poorly understood. Particularly, no study investigated the relationship between post-stroke trajectories of activities of daily living (ADL) and self-rated health (SRH). However, such knowledge is of major importance to identify patients at risk of unfavourable courses. This prospective observational study aims to investigate trajectories of ADL and SRH, and their modifying factors in the course of the first year after stroke.
The study will consecutively enrol 300 patients admitted to a tertiary care hospital with acute ischaemic stroke or transient ischaemic attack (TIA; Age, Blood Pressure, Clinical Features, Duration of symptoms, Diabetes score ≥3). Patient inclusion is planned from May 2021 to September 2022. All participants will complete an interview assessing ADL, SRH, mental health, views on ageing and resilience-related concepts. Participants will be interviewed face-to-face 1-5 days post-stroke/TIA in the hospital; and will be followed up after 6 weeks, 3 months, 6 months and 12 months via telephone. The 12-month follow-up will also include a neurological assessment. Primary endpoints are ADL operationalised by modified Rankin Scale scores and SRH. Secondary outcomes are further measures of ADL, functional health, physical activity, falls and fatigue. Views on ageing, social support, resilience-related concepts, affect, frailty, illness perceptions and loneliness will be examined as modifying factors. Analyses will investigate the bidirectional relationship between SRH and ADL using bivariate latent change score models.
The study has been approved by the institutional review board of the University Medicine Greifswald (Ref. BB 237/20). The results will be disseminated through scientific publications, conferences and media. Moreover, study results and potential implications will be discussed with patient representatives.
NCT04704635.
中风是欧洲导致成年人长期残疾的主要神经原因。尽管与神经损伤直接相关的功能后果已经得到了很好的研究，但根据《国际功能、残疾和健康分类》，中风后功能健康的轨迹仍知之甚少。特别是，没有研究调查中风后日常生活活动（ADL）和自我报告健康（SRH）的轨迹之间的关系。然而，这种知识对于识别有不良病程风险的患者非常重要。这项前瞻性观察研究旨在调查中风后第一年 ADL 和 SRH 的轨迹及其影响因素。
该研究将连续纳入 300 名因急性缺血性中风或短暂性脑缺血发作（TIA）入住三级医院的患者（年龄、血压、临床特征、症状持续时间、糖尿病评分≥3）。预计从 2021 年 5 月到 2022 年 9 月进行患者纳入。所有参与者将完成一项评估 ADL、SRH、心理健康、衰老观和与复原力相关概念的访谈。参与者将在中风/TIA 后 1-5 天在医院接受面对面访谈；并将在 6 周、3 个月、6 个月和 12 个月通过电话进行随访。12 个月的随访还将包括神经学评估。主要终点是改良 Rankin 量表评分的 ADL 操作化和 SRH。次要结局是进一步的 ADL 测量、功能健康、身体活动、跌倒和疲劳。衰老观、社会支持、与复原力相关的概念、情感、脆弱性、疾病认知和孤独感将被作为调节因素进行检查。使用双变量潜在变化分数模型，将分析 SRH 和 ADL 之间的双向关系。
该研究已获得格赖夫斯瓦尔德大学医学伦理委员会的批准（参考号：BB 237/20）。研究结果将通过科学出版物、会议和媒体进行传播。此外，还将与患者代表讨论研究结果及其潜在影响。
NCT04704635。
