Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- physical scale of the Stroke Impact Scale 3.0
研究概览
简要总结
Primary objective of this study is to determine whether a case management of stroke patients after discharge to home or to nursing home results in improving physical and cognitive capacity one year after discharge.
详细描述
In a randomized trial, the project Participative rehabilitation process management "Stroke in Saxony-Anhalt" (PaReSiS) implements a case management trial, explicitly including all providers in the course of illness, treatment and rehabilitation. To achieve this, patients in the intervention group have the opportunity to choose, specifically and according to their own needs, from the offers of a web portal and a telephone hotline, from individual counselling and info sessions as well as from home visits. Patients in the control group receive patient-information-notes beyond primary care. There will be qualitative interviews with the persons concerned and/or their relatives in both groups in order to validate the instruments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding) with signs and symptoms of an acute stroke according to the diagnosis I61 and I63 of the ICD-10-GM 2008
- •Differentiation between ischemic or haemorrhagic stroke by the use of CT or MRT
- •Resident in Saxony-Anhalt or Saxony or Thuringia
- •Able to understand German language
排除标准
- •Reinfarction
- •Alcoholism
- •Death in acute care
- •NIHHS > 25
- •Homelessness
结局指标
主要结局
physical scale of the Stroke Impact Scale 3.0
时间窗: before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization
次要结局
- Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND(before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization)
研究者
Johann Behrens
Prof. Dr. phil. habil.
Martin-Luther-Universität Halle-Wittenberg