Early Supported Discharge After Stroke in Bergen. An RCT Looking at the Collaboration Between Hospital Service and Primary Health Care.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- MRS
研究概览
简要总结
The main purpose of this study is to evaluate the benefit of early supported discharge (ESD) in rehabilitation of stroke patients in two different outpatient modalities.
In a collaborating study, changes in physical function as well as the patients' own perception of physical function, pain and fatigue will be studied. In further collaborating studies, health economics and organizational issues will also be evaluated.
详细描述
Early supported discharge (ESD) seems to be at least as effective as hospital rehabilitation after stroke, and possibly better. In this study patients with recent stroke will be randomized to one of three different treatment arms:
- ESD with treatment at a day institution until 4 hrs. per day for up to 5 weeks
- ESD with treatment in the patients' home until 4 hrs. per day for up to 5 weeks
- Rehabilitation treatment "as usual", with a longer hospital stay, but without any specific treatment or follow-up after discharge
The patients in the two ESD arms will in addition be followed closely by a multidisciplinary coordinating team during the stay in hospital and the 5 week period of treatment after discharge, and they will be offered follow-ups at 3 and 6 months after inclusion into the study.
Patients in all 3 arms will be systematically examined with a set of measuring instruments as well as objective physical and function tests. This will be performed at inclusion and at 3, 6, 12 and 24 months after inclusion.
In the collaborating study by physiotherapist Bente Gjelsvik a comparison between changes in trunk control, balance, walking and ADL 3 months post stroke, as well as the patients' perceptions of physical function, pain and fatigue, will be the main focus. To assess function, functional change and possible differences between different interventions, there is a need for reliable and valid outcome measures. As a basis for the use of the outcome measure Trunk Impairment Scale (TIS) in this study, the TIS has been translated into Norwegian, Trunk Impairment Scale - Norwegian version (TIS-NV) and will be examined for measurement properties using data from the above study as well as data from patients with brain damage recruited from the Department of Physical Rehabilitation Medicine, Haukeland University Hospital. An examination of a possible connection between localisation and size of the stroke and trunk control will also be performed, as characteristics of the stroke may have therapeutic implications for the choice of intervention for the individual patient. The research questions for the planned doctoral thesis for Bente Gjelsvik are therefore as follows:
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Living in own home in the community of Bergen, Norway
- •Inclusion within 1-7 days (24-168 hours) after debut of symptoms
- •Inclusion within 6-120 hours after admission to Department of Neurology
- •NIHSS score 2-26 at inclusion OR NIHSS score < 2 if Modified Rankin Scale is 2 or higher when being 0 before the stroke
- •The patient must be awake and informed consent must be given by patient or relatives
排除标准
- •Serious psychic illness
- •Serious drug abuse
- •Serious medical conditions that can influence the patients' cerebrovascular disease or rehabilitation
- •Poor knowledge of the Norwegian language
结局指标
主要结局
MRS
时间窗: 6 months
Modified Rankin Scale
次要结局
- TIS(3 and 6 months)
- TUG (Timed Up and Go)(3 and 6 months)
- NRS (Numeric Rating Scale)(3 and 6 months)
- Norwegian Basic Test for Aphasia(3 and 12 months)
- BI(3, 6, 12 and 24 months)
- NIHSS(3, 6 and 12 months)
- SIS(12 months)
- RSS(12 months)
- AMPS(3 and 6 months)
- PGIC(12 and 24 months)
- SF-36(12 and 24 months)
- 5mTW (5 meter Timed Walk)(3 and 6 months)
- MRS(3, 12 and 24 months)
- PASS (Postural Assessment Scale for Stroke)(3 and 6 months)