Randomised Controlled Trial of an Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Stroke and Aphasia Quality of Life Scale-39
研究概览
简要总结
Research question Does participation in an Intensive Comprehensive Aphasia Programme produce a meaningful change in the communication of people with aphasia, their quality of life and that of their carers?
Background Aphasia is a persistent language disorder that severely impairs communicative abilities. Most commonly induced by a stroke, aphasia reduces quality of life more than any other condition. People with aphasia (PWA) and their carers feel abandoned by the NHS due to the limited treatment options available. Meanwhile, neuroscientific evidence suggests that PWA can make meaningful gains in communicative ability, mood, and quality of life if therapists are given enough time to work with them. Although studies indicate Intensive Comprehensive Aphasia Programmes (ICAPs) are effective ways to deliver such therapy, no randomised controlled trial (RCT) of an ICAP has yet been conducted. the investigators propose conducting the first ever ICAP RCT.
Aims and objectives Clinical: i) To test the efficacy of an ICAP in improving PWAs' language impairment, communicative ability, mood, and quality of life; ii) to measure the quantity and quality of therapy received in the community by the standard care group; iii) to assess the significance of age and time-since-stroke in PWA's responses to ICAP intervention.
Mechanistic: To test whether combining baseline behaviour and MRI brain scans can usefully predict individual patients' responses to the ICAP treatment.
Methods The RCT will test the effect of an ICAP intervention by randomly assigning PWA and their carers to one of two groups receiving either ICAP or standard care at two participating sites. The investigators aim to deliver 100 hours of ICAP therapy over a 4-week schedule to adult PWA who are more than 3 months post-stroke. The investigators will compare the effects of the ICAP, comprising complex interventions with multiple interacting therapeutic components, with standard care, the quantity and quality of which will be recorded by research assistants. The primary outcome measure is a standardized scale for measuring quality of life for PWA (SAQOL-39g). The primary endpoint is 4 months post-randomisation. The investigators will also test for effects at 9 months.
Anticipated impacts The trial could provide the evidence needed to transform how the NHS treats PWA and their carers. If the investigators demonstrate that participating in an ICAP leads to clinically meaningful and sustained improvements, the next stage in achieving wider NHS roll-out will be a multi-centre trial to investigate the cost- and clinical effectiveness of ICAPs across the UK.
详细描述
BACKGROUND AND RATIONALE Why is this research needed now? Aphasia is a distressing and increasingly prevalent condition Aphasia is an acquired disorder of language that often persists as a lifelong condition following a brain injury. A stroke is by far the commonest cause, with aphasia experienced by a third of stroke survivors.
In a study of over 66,000 people dependent on others for care, aphasia was rated worse than 75 conditions associated with poor quality of life, including cancer, dementia, quadriplegia, and motor-neurone-disease.
The Stroke Association estimates 350,000 people have post-stroke aphasia in the UK, and this number is set to increase significantly. Although new cases of stroke in high-income countries are decreasing by around 1% per year across all age bands, the aging populations of these countries mean the number of people living with stroke will double by 2035. The prevalence of PWA will thus rise despite the lower incidence of strokes.
Effective speech and language rehabilitation has an increasingly important role to play at a time when the numbers of PWA are rising and receiving ever-fewer resources.
Current speech and language therapy approaches are effective but PWA remain massively under-dosed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (>18 years old) PWA caused by stroke
- •More than 3 months post-stroke
- •Can use English to communicate (even if not as their first language)
- •Carers will be nominated (if available) by individual PWA
排除标准
- •Severe speech apraxia (no meaningful spoken word output)
- •Severe fatigue or other reasons they cannot commit to the timing and duration of the ICAP
- •Ongoing debilitating psychiatric disorders (e.g. psychosis, but not low mood)
- •Co-existing neurological disorders affecting engagement (e.g. dementia).
研究组 & 干预措施
Intensive Comprehensive Aphasia Programme
As defined by the new framework commissioned by the NIHR and the MRC [44], ICAPs are complex interventions with multiple interacting components. We have published our ICAP operating manual using the TIDieR format (Template for Intervention Description and Replication) to ensure it complies with intentionally accepted requirements (see uploads) [45, 46] Accordingly, no individual PWA or their carer will receive all possible therapeutic components; instead, the therapists will personalise content according to individual needs to help them achieve their goals. A further key feature of the ICAP is that the treating therapists (4 Speech and Language Therapists and one Clinical Psychologist) work as a team, meaning all of them will work with each PWA over the 4-week ICAP.
干预措施: ICAP (Behavioral)
Control (standard care)
Although the amount of therapy received by PWA in the community varies, the most in-depth study of this variation across 21 UK-based SLT departments concludes as follows: "Where resources are in short supply, therapists have the difficult ethical decision of providing therapeutic levels of intervention to some patients, or providing sub therapeutic levels to all. Currently it looks as if the latter is most common in practice."[48] This study found the majority of PWA over a year post-stroke were not receiving any therapy, while a minority were receiving ~6.3 hours, ranging widely from 0.5-41.5 hours. To capture the quantity and quality of the therapy received by PWA in this arm (and the ICAP group once they complete the ICAP) we will ensure the research team complete the relevant sections of the Client Service Receipt Inventory at each time point
干预措施: Standard Care (in control arm) (Behavioral)
结局指标
主要结局
Stroke and Aphasia Quality of Life Scale-39
时间窗: Four months post allocation to interventio or control arm.
The primary outcome measure will be a standardized scale for measuring quality of life for PWA. The primary endpoint is at 4 months, i.e. 3 months post-ICAP. Likert scale (1-5 for each question). High scores = better outcome. The main score is reported as an average of all scores but there are three subscales: Communication, psychosocial and physical. The investigators expect changes in communication and psychosocial but not physical subscores. Min = 1, Max = 5
Structural MRI brain scan
时间窗: Four months post treatment-allocation
By using a high-resolution MRI brain scan prior to therapy, we will provide a mechanistic account of the effects of the ICAP on PWA's speech production and speech comprehension gains.
次要结局
- Comprehensive Aphasia Test(Baseline, 1-month, 4-month and 9-month post treatment-allocation)
- Communicative Effectiveness Index(Baseline, 4-month and 9-month post treatment-allocation)
- Communicative Participation Item Bank(Baseline, 1-month, 4-month and 9-month post treatment-allocation)
- Stroke Aphasic Depression Questionnaire(Baseline, 4-month and 9-month post treatment-allocation)
- General Health Questionnaire-12(Baseline, 4-month and 9-month post treatment-allocation)
- Goal Assessment Scale(Baseline, 1-month, 4-month and 9-month post treatment-allocation)
- Client Service Receipt Inventory(Baseline, 1-month, 4-month and 9-month post treatment-allocation)
- Adult Carers Quality Of Life Questionnaire(Baseline, 4-month and 9-month post treatment-allocation)
- Zarit Burden Interview(Baseline, 4-month and 9-month post treatment-allocation)
- Patient Health Questionnaire-9(Baseline, 4-month and 9-month post treatment-allocation)
- ICAP Questionnaire for Person With Aphasia(9 months (final time point))
- ICAP Questionnaire For the carers(9 months (final time point))