ACT NoW: Assessing the Effectiveness of Communication Therapy in the North West: a Pragmatic, Multi-centre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- The primary outcome will be functional communicative ability
研究概览
简要总结
Assessing Communication Therapy in the North West (ACT NoW) is a research project which aims to evaluate the effectiveness, cost effectiveness and service user preferences for communication therapy following stroke when compared to an attention control.
详细描述
Stroke is the leading cause of long-term disability in the UK. About a third of stroke survivors will suffer some level of communication problems following the stroke. Such problems can affect parts or all of the motor apparatus responsible for producing speech, thus affecting clarity of speech and overall intelligibility (a condition known as dysarthria). Alternatively, stroke can affect the cognitive system for comprehending and formulating language (a condition known as dysphasia or aphasia). Some people will suffer impairment of both speech and language.
For these people, Speech and Language Therapy is often offered. Solid research evidence is a pre-requisite for planning evidence-based service delivery and systematic reviews for dysarthria and aphasia highlighted a lack of good quality research evidence of the effectiveness of Speech and Language Therapy. To try and rectify this situation, the ACT NoW study has been commissioned and funded by the NIHR Health Technology Assessment Programme.
The aims of the ACT NoW Study are to determine the relative effectiveness and cost effectiveness of a Speech and Language Therapy (SLT) intervention for people with aphasia and/or dysarthria following stroke, when compared with an attention control. We also aim to explore the experience and the impact of the interventions from the perspective of both users and carers, using qualitative research.
The ACT NoW study is a pragmatic, multi-centre randomize controlled trial (RCT) with a nested qualitative study and full economic evaluation. The RCT involves comparison of two arms within this target population: a manualized Speech and Language Therapy (SLT) intervention; and an 'attention control'. Randomization will be stratified by diagnosis/severity as well as site/centre, with an 'intention to treat' approach.
The qualitative study will comprise interviews with patients and carers, purposefully sampled from each arm of the trial, to evaluate service user preferences for communication therapy after stroke. Innovative methods of communication support have been developed to enable people with communication difficulties to engage in the interview process.
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
- 否
入选标准
- •Adults diagnosed with aphasia and/or dysarthria following admission to hospital with a new stroke
排除标准
- •Subarachnoid haemorrhage
- •Pre-existing, progressive dementia or learning difficulties
- •Not able to receive therapy in the English language
- •Resident outside treatment area
- •Expected recovery without therapy
结局指标
主要结局
The primary outcome will be functional communicative ability
时间窗: 6 months post randomisation
次要结局
- The economic analysis to estimate incremental cost effectiveness and net benefit of the intervention. Qualitative study to examine service users' and carers' perspectives Speech and Language Therapy vs control treatment.(6 months post randomisation)
