POst Stroke Intervention Trial in Fatigue: A Randomised Controlled Trial of a Brief Intervention for Post-stroke Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Fatigue Assessment Scale (FAS)
研究概览
简要总结
The purpose of this study is to assess whether a brief cognitive behavioural intervention for post-stroke fatigue leads to clinically relevant improvements in fatigue after 6 months.
详细描述
Primary Objective
Does a brief cognitive behavioural intervention for post-stroke fatigue lead to clinically relevant improvements in fatigue after 6 months? Fatigue will be assessed using the self-reported Fatigue Assessment Scale (FAS) which has been validated for use in stroke (14). This scale includes both mental and physical fatigue. Our data shows that a difference of approximately 5 points in FAS was associated with a clinically significant difference in people with stroke (15); the literature on stroke patients suggests that a difference in four points on the scale is considered to be 'clinically relevant'. We are conservatively basing our power calculations on a difference between groups of four points in the FAS.
Secondary Objectives
- Does the intervention improve fatigue at 4 months (i.e. immediately after the end of the intervention)?
- Does the intervention improve self-reported mood at 4 months and 6 months? This will be assessed using Patient Health Questionnaire (PHQ-9) (16) and the Generalised Anxiety Disorder (GAD7) (17). At 6 months we will also enquire whether antidepressants or anxiolytics have been prescribed.
- Does the intervention improve stroke specific quality of life including patient reported social participation? This will be assessed using the Modified Short Form of the Stroke Impact Scale (18).
- What is the cost of the intervention, and what is the quality of life adjusted life years (QUALYS)? To assess QUALYS, we will use the Euroquol 5D (5 level version) (21).
- Has the patient returned to work? If so are they working the same hours as prestroke?
Endpoints
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
盲法说明
The patient and the person delivering the intervention will not be blind to treatment 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
- •Age ≥ 18 years
- •Stroke 3 months to 2 years previously. Both ischaemic and haemorrhagic, including subarachnoid haemorrhage
- •Capacity to consent
- •Not living in nursing home.
- •Medically stable,
- •Answers 'Yes' to both the following questions about fatigue
- •'Do you feel tired all the time or get tired very quickly since your stroke'?
- •Would you like additional help and support for this?
排除标准
- •Unlikely to be available for follow-up for the next 6 months e.g. no fixed home address
- •Other life-threatening illness (e.g. advanced cancer or advanced heart failure) that will make survival for 6 months unlikely
- •Aphasia or cognitive impairment which is severe enough to prevent participation in the intervention. To assess this, patients will self-report their language and cognition from the relevant domains in the Short Stroke Impact Scale ('In the past week, how difficult was it for you to think quickly?' and 'In the past week, how difficult was it to understand what was being said to you in a conversation?') Those who respond 'very difficult' or 'could not do at all' to either question will be excluded. (24). Those who might be in these categories are likely to be unable to complete the form(s) and thus self-select to decline to return the paperwork.
- •Actively suicidal, requiring in-patient treatment for depression, depression related cognitive impairment. (see below)
- •High anxiety as part of a post-traumatic stress disorder syndrome or panic disorder (see below)
- •Previously enrolled in this trial
- •Enrolled in another talking therapy trial
- •Inability to understand spoken and/or written English
结局指标
主要结局
Fatigue Assessment Scale (FAS)
时间窗: 6 months after randomisation
The FAS is a 10-item self-report scale with 10 statements about different aspects of fatigue, each rated from 1 to 5 (1, never; 2, sometimes; 3, regularly; 4, often; and 5, always). It is valid and reliable in stroke. A higher score indicates more fatigue. A difference of four points is considered to be clinically relevant.
次要结局
- PHQ-9(4 months and 6 months after randomisation)
- Health costs(Between randomisation and 6 months)
- List of patient's medication(Between randomisation and 6 months)
- Modified Short Form of the Stroke Impact Scale(6 months after randomisation)
- EuroQuol (EQ-5D-5L)(Baseline, 4 months and 6 months after randomisation)
- GAD-7(4 months and 6 months after randomisation)