Randomised Controlled Trial of an Intensive Comprehensive Aphasia Programme for People with Post-Stroke Aphasia

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. We 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 Our 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. We aim to deliver 100 hours of ICAP therapy over a 4-week schedule to adult PWA who are between 3–48 months post-stroke. We 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. We will also test for effects at 12 months. Anticipated impacts Our trial could provide the evidence needed to transform how the NHS treats PWA and their carers. If we 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.