A Multimodal Individualized Intervention to Prevent Functional Decline After Stroke. A Randomized Controlled Trial on Long-term Follow-up After Stroke (The LAST-long Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 5
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
Despite the improved treatment of acute stroke over the past decades, those suffering from stroke still are at an increased risk of functional and cognitive decline in the long term. The most common consequences of stroke are functional impairments, cognitive impairments, depression and fatigue. These are also regarded as barriers to achieve optimal adherence to the guidelines regarding secondary prevention. The primary aim of this project is to evaluate the effectiveness of a multimodal individualized intervention to prevent functional decline in the long term after stroke.
详细描述
In a clinical randomized controlled trial, participants randomized to the intervention arm will be followed with monthly meetings by a stroke coordinator for 18 months.
The stroke coordinator will assess the patients risk factors within the domains of physical function, cognitive function, social function, medication and lifestyle factors and make a treatment plan targeting the individual needs for further follow-up.
Those randomized to the control group will receive standard care.
Patients living in the municipalities of Trondheim, Lørenskog and Skedsmo admitted to Akershus University Hospital or St. Olavs University Hospital will be included at the outpatients clinic 3 months after the stroke.
All patients will be re-assessed at 6, 12 and 18 months after inclusion. Primary outcome will be modified Rankin Scale at 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Single-blinded. The investigator and outcomes assessor will be blinded to group allocation.
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 first ever or recurrent stroke (ischemic stroke or hemorrhage)
- •Living in Trondheim, Skedsmo or Lørenskog municipality
- •Less than 10 points on Short Physical Performance Battery (SPPB) OR less than 26 points on Montreal Cognitive Assessment (MoCA) OR more than 27 points on the 7 item version of the Fatigue Severity Scale (FSS-7) OR more than 7 points on the depression or anxiety items on Hospital Anxiety and Depression Scale (HADS) OR reduced hand function (i.e. fails on Motor Assessment Scale - Advanced arm- and hand function, item 3)
- •Able to understand Norwegian
- •Able and willing to sign informed consent.
排除标准
- •Life expectancy < 12 months
- •Other serious diseases, judged by the medical doctor to make it difficult to comply with the intervention (i.e. serious neurological diseases or drug abuse).
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 18 months
mRS is an ordinal scale ranging from 0 to 6 measuring global function. 0 denotes no symptoms while 6 denotes death.
次要结局
- Longterm blood sugar (HbA1c)(18 months)
- Barthel Index(18 months)
- Short Physical Performance Battery(18 months)
- Dynamometer(18 months)
- 6 Minute Walk Test(18 months)
- ActivPAL(18 months)
- Nottingham IADL(18 months)
- The 5-level EQ-5D version (EQ-5D-5L)(18 months)
- Hospital Anxiety and Depression Scale (HADS)(18 months)
- Stroke Impact Scale (SIS)(18 months)
- Short Physical Performance Battery (SPPB)(12 months)
- Total cholesterol(18 months)
- Body mass index (BMI)(18 months)
- Modified Rankin Scale (mRS)(12 months)
- Montreal Cognitive Assessment(18 months)
- Global Deterioration Scale (GDS)(18 months)
- Part 2 of the Client Service Receipt Inventory(18 months)
- Low Density Lipoprotein (LDL)(18 months)
- High Density Lipoprotein (HDL)(18 months)
- Hemoglobin(18 months)
- Health care costs(18 months)
- Patient diaries(18 months)
- Adverse events(18 months)
- Adherence to the intervention(18 months)
- Trail making test A and B(18 months)
- Fatigue Severity Scale (FSS-7)(18 months)
- Creatinine(18 months)
- Blood pressure(18 months)
- C-reactive protein (CRP)(18 months)
- Exercise Adherence Rating Scale(18 months)