Life After Transient Ischemic Attack: A 12-months Prospective Cohort Study: The LATIA Cohort
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- Presence of fatigue at 3 months
研究概览
简要总结
Background: Transient ischemic attack (TIA) is defined as acute neurological symptoms of vascular origin, which resolves completely within 24 hours. However, emerging evidence indicates that up to 1/3 of patients is experiencing (non-focal) lasting symptoms, such as fatigue, depression, and anxiety.
Aim: The aim of this study is to investigate self-reported lasting symptoms after TIA, timing of these symptoms as well as their potential resolution and characterize patients who have high risk for developing these symptoms.
Method: This is a prospective cohort study which will include 350-400 patients with TIA from a single comprehensive stroke care center which serves the population in North Denmark Region, one of five administrative regions in Denmark (Stroke Unit, Aalborg University Hospital). Outcome measures include patient-reported outcomes collected at discharge, 3, 6 and 12 months and semi-structured interviews with a selected sample of patients.
Perspective: This study will provide much needed insights into the development of lasting symptoms in patients with TIA in a cohort with presumed high external validity. Based on these results, a person-centered intervention will be designed to support the return to everyday life for patients with TIA.
详细描述
Background:
In Denmark approximately 4.000 patients every year are diagnosed with Transient Ischemic Attack (TIA). In Denmark the time-based definition of TIA is used and based on a clinical assessment with acute, often focal neurological symptoms of vascular origin resolving completely within 24 hours. Emerging evidence suggests however, that 1/3 of patients experience lasting symptoms as cognitive impairments, depression, anxiety and/or fatigue, which may impact their ability to return to their normal everyday life. Patients' own perception of a complex and life-altering experience has been identified in the qualitative literature. Some patients experiencing lasting symptoms and alterations in multiple life domains like a feeling of uncertainty, vulnerability, instability and change. According to this review, some patients reported that physical and psychosocial symptoms were not recognized, nor acknowledged by their healthcare professionals. Education for clinicians was recommend to enable them to understand these difficulties, improve interaction and meet the patients' needs.
It is unknown which patients are at increased risk of experiencing the described lasting symptoms when these symptoms arise and how it affects quality of life and return to everyday life. Answers to these questions will allow the design and test of an evidence-based and patient-centered intervention. The ultimate goal will be the creation of an evidence-based guide on how to follow-up and intervene in patients with TIA to ensure the return to their everyday life.
Aim:
The aim of this study is to investigate self-reported lasting symptoms after TIA, timing of these symptoms as well as their potential resolution and characterize patients who have high risk for developing these symptoms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of TIA (ICD-10 code DG45, except DG45.3 Amaurosis fugax and DG45.4 Global Transient Amnesia) and for a) accumulated TIA (>1 event within the last 30 days): contact to the healthcare system within 30 days from symptom onset, b) not-accumulated TIA: contact to the healthcare system within 7 days from symptom onset. (as defined in the Danish Stroke Registry)
- •Minimum 18 years of age
- •Availability for follow-up during the study period
- •Able to read and understand Danish
- •Able to fill out questionnaires (assessed by the associated healthcare professional)
- •Not included in any other research projects
排除标准
- 未提供
结局指标
主要结局
Presence of fatigue at 3 months
时间窗: 3 months after event
Fatigue using the Multidimensional Fatigue Inventory
次要结局
- Level of function immediately and 3-, 6- and 12-months after discharge(1-2 weeks, 3-, 6- and 12-months after discharge)
- Patients experience of their quality of life immediately and 3-, 6- and 12-months after discharge(1-2 weeks, 3-, 6- and 12-months after discharge)
- Qualitative interviews To provide a deeper understanding of the experiences with and impact of TIA on everyday life(4 months after discharge)
- Patients ability to manage everyday life and differences in pre- and post-TIA status immediately and 3-, 6- and 12-months after discharge(1-2 weeks, 3-, 6- and 12-months after discharge)
- Presence of fatigue immediately and 3-, 6- and 12-months after discharge(1-2 weeks, 6- and 12-months after discharge)
- Presence of depression and anxiety immediately and 3-, 6- and 12-months after discharge(1-2 weeks, 3-, 6- and 12-months after discharge)
- Patients experience of well-being immediately and 3-, 6- and 12-months after discharge(1-2 weeks, 3-, 6- and 12-months after discharge)
- The patients ability to obtain information and knowledge to maintain and improve health using questions on health literacy(1-2 weeks, 3-, 6- and 12-months after discharge)
- Patient experienced outcomes of lasting symptoms (if any) and how these affect everyday life(1-2 weeks, 3-, 6- and 12-months after discharge)
研究者
Birgitte Hede Ebbesen
Principal Investigator
Aalborg University Hospital