About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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).
Trial design
Treatments tested in this trial
- ICAP
- Standard Care (in control arm)
Treatment groups
Sponsors and collaborators
University College, London
Lead sponsor
St George's University Hospitals NHS Foundation Trust
Collaborator
University College London Hospitals
Collaborator
City, University of London
Collaborator