Clinical Effectiveness of Self-Management Education Post-Mild Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Healthcare Utilization Survey (HCUS)
研究概览
简要总结
Individuals who have a mild stroke have a 44% risk of dying from a second stroke within 10 years which is in large part due to the cyclical relationship of chronic disease, poor health, and mild stroke which has gone largely unnoticed in the United States. Self-management intervention has been proven to be an effective intervention to increase healthy behaviors, improve overall health status, decrease healthcare utilization/cost, decrease depressive symptoms, and improve participation in people with a variety of chronic conditions; however, it has never be used with individuals with mild stroke. The critical next step and goal of this study is to evaluate if self-management intervention will improve health outcomes for persons with mild stroke. The overall hypothesis of this study is that self-management intervention will improve outcomes in the mild-stroke population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a mild stroke as NIHSS total scores 0-5
- •18-90 years of age
- •English speaking
- •identified as having at least one other chronic condition besides stroke
排除标准
- •severe aphasia (NIHSS aphasia score=2)
- •moderate to severe cognitive impairment (MOCA < 21)
- •history of dementia
- •hemorrhagic stroke
- •neurological diagnoses other than stroke
- •major psychiatric illness (A diagnosis of bipolar disorder, obsessive compulsive disorder, panic disorder, schizophrenia, post-traumatic stress disorder, and borderline personality disorder)
- •a score of no-higher than 20 on the PHQ-9 indicating significant depressive symptoms
- •terminal illness
结局指标
主要结局
Healthcare Utilization Survey (HCUS)
时间窗: Change from baseline to 6-months post-stroke
Adapted Illness Intrusiveness Ratings (AIIR)
时间窗: Change from baseline to 6-months post-stroke
次要结局
- Multidimensional Assessment of Fatigue (MAF)(Change from baseline to 6-months post-stroke)
- Stroke Impact Scale (SIS)(Change from baseline to 6-months post-stroke)
- Reintegration to Normal Living Index (RNLI)(Change from baseline to 6-months post-stroke)
- Patient Health Questionnaire (PHQ-9)(Change from baseline to 6-months post-stroke)
- Work Ability Index (WAI)(Change from baseline to 6-months post-stroke)
- World Health Organization Quality of Life (WHOQOL-BREF)(Change from baseline to 6-months post-stroke)
- Chronic Disease Self-Efficacy Scale (CDSES)(Change from baseline to 6-months post-stroke)
- Activity Card Sort (ACS)(Change from baseline to 6-months post-stroke)