Multifaceted Intervention to Reduce Recurrent Cardiovascular Events and Improve Quality-of-Life After Ischemic Stroke and High-Risk Transient Ischemic Attack (TIA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,149
- 试验地点
- 2
- 主要终点
- Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score)
研究概览
简要总结
Patients after ischemic stroke are at high risk of recurrent cardiovascular events and of developing post-stroke complications. There is a substantial gap between risk factor management in real life and that recommended by international guidelines. Stroke Card is a multifaceted comprehensive post-stroke disease management program to detect and treat complications and optimize secondary prevention. The investigators hypothesize that, compared to standard care, Stroke Card will lead to an at least 33.3% risk reduction in recurrent cardiovascular events and improve health-related quality-of-life.
详细描述
Stroke is the leading cause of disability and morbidity in the Western world and will extend its lead based on the continuous aging of European populations. Apart from persistent deficits, potentially avoidable medium- and long-term complications are significant contributors to post-stroke functional impairment and an appealing target for concerted interventions. Moreover, there is a substantial gap between risk factor management in real life and that recommended by international guidelines, resulting in a large number of avoidable recurring events.
Stroke Card is a prospective block-randomized open interventional trial with blinded outcome assessment comparing two standards of post-stroke patient care which both comply with the current state-of-the-art. Consecutive patients treated at the Department of Neurology of the University Hospital Innsbruck with ischemic stroke or high-risk TIA will be allocated to either standard care or extended standard care according to the Stroke Card concept and will be enrolled during the initial hospital stay. A second study center (Hospital St. John of God Vienna) is also enrolling patients. The program complies with the respective guidelines of the American Heart Association (AHA), focuses on patient empowerment, patient self-management education, routine reporting to the general practitioner (GP), evidence-based decision making, shared knowledge, and cooperation among physicians.
Whereas disease management programs typically rely on expert opinion, our initiative moves from a purely empirical approach to a highly structured, individualized and evidence-based procedure with an outcome and health economy analysis.
Generic objectives:
Early detection or prevention of post-stroke complications, estimation of the patient's demand for nursing services and support, guideline-conform secondary prevention with full achievement of target levels, lifestyle modifications and outcome assessment after 3 and 12 months, assessment of 12-Mo body functioning (impairment), activity (disability) and participation (handicap and quality-of-life (QoL)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with acute ischemic stroke or high-risk TIA (ABCD2≥3)
- •Age ≥ 18 years
- •Written informed consent
排除标准
- •Patients living outside the hospital catchment area
- •Malignant or other severe disease with life-expectancy less than the expected duration of the trial
- •Drug addiction or severe alcohol abuse
- •Patients with persistent severe disability ad discharge (mRS=5) not suitable for rehabilitation (this group will have outcome and complication assessment by a telephone interview with the caregivers according to current standards)
研究组 & 干预措施
Extended Standard Care (Stroke Card)
干预措施: Active Comparator: Extended Standard Care (Stroke Card) (Behavioral)
Standard Care
干预措施: Active Comparator: Standard Care (Behavioral)
结局指标
主要结局
Health-related QoL (European Quality of Life-5 Dimensions EQ-5D-3L - overall health utility score)
时间窗: at one year
Co-primary endpoint
Major recurrent (post-discharge) cardiovascular events [nonfatal stroke, nonfatal myocardial infarction, and vascular death]
时间窗: one year
次要结局
- Functional outcome(at one year)
- Death from all causes(one year)
- Target level achievement in secondary prevention(at one year)
- Recurrent stroke (both ischemic and hemorrhagic) and TIA(one year)
- Quality-of-Life 5 individual dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety and depression)(at one year)
研究者
Stefan Kiechl
A.Univ.-Prof.
Medical University Innsbruck
