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.

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.

Evidence from meta-analyses of interventional studies on PWA confirms the importance of sufficient therapy dose for achieving clinically meaningful change: a seminal meta-analysis suggested 100 hours; the latest Cochrane review suggests 60-208 hours; and the most recent evidence from the RELEASE project indicates that 3-5 days of therapy per week leads to the greatest gains in overall language and functional communication.

Given this evidence, the challenge is how to deliver sufficiently high doses of contact with expert coaches (therapists) to make a difference to PWA. Although evidence from some aphasia studies supports theoretical claims that spacing out therapy may be beneficial, economic factors have driven a rise in intensive programmes (ICAPs) as a way of providing large doses over short time scales. This is essentially because therapy teams working at single sites are more efficient than peripatetic solo therapists.

The aim of ICAPs is to produce a step-change in language function sufficient to enable PWA to engage more effectively with others and to continue to maintain and even boost any ICAP-related gains in communication.

ICAP DEFINITION AND EVIDENCE The minimum number of contact hours for a service to be considered an ICAP is 3 hours a day for two weeks, i.e. >30 hours in total, which is far more than most community-based PWA ever receive. To date, nine ICAPs that have treated 10 or more PWA have published their findings. In sum, most have demonstrated medium to large effects on key language impairment and functional outcome measures.

Carers count too! The ICAP will specifically target carers of PWA Over half of all PWA depend on support from carers for everyday activities and emotional health. Most carers are spouses, family members, or other close contacts of PWA. Caring for PWA is strongly associated with emotional distress and feeling overburdened.

AIMS, OBJECTIVES AND ENDPOINTS

The investigators will address 3 key gaps in the current evidence base that need resolving before wider implementation of ICAPs can proceed:

1. The investigators will conduct the first ever RCT of an ICAP to test if the clinical effect sizes are as large as observational studies have reported. If ICAPs are to be rolled-out in the NHS, the investigators need to demonstrate what the true effect sizes are by comparing the ICAP with a matched sample of PWA undergoing standard care (reflecting current practices).
2. The investigators will carry out secondary analyses to see if two key PWA variables significantly affect the main result: 1) the age of PWA and 2) time-since-stroke. This will help personalise ICAP provision if either or both variables prove important modulators of therapy effects.
3. By using a high-resolution MRI brain scan prior to therapy, the investigators will provide a mechanistic account of the effects of the ICAP on PWA's speech production and speech comprehension gains. This will enable future stratification of PWAs based on brain imaging.

Clinical Objectives

1. To test whether an ICAP produces a clinically meaningful improvement in PWA's language impairment, communicative ability, mood and quality of life compared with standard care.
2. To measure the quantity and types of intervention that PWA receive in the community (both groups).
3. To investigate whether age and time-since-stroke are significant factors in determining PWAs' response to an ICAP.

Mechanistic Objectives

1. To test whether individual responses to ICAP treatment are predictable, i.e. whether the investigators can best predict individual outcomes based on a person's baseline behaviour and MRI brain scan.
2. To test whether ICAP-driven improvements in language production and comprehension among individual PWA depend on the intactness of different brain regions.

TRIAL DESIGN The ICAP will be evaluated as a 2-arm group RCT across two sites: North London (Queen Square) and South London (St. George's). The comparator will be 'standard care', the quantity and quality of which will be recorded using the Client Service Receipt Inventory.

Allocation to these groups will be on a 1:1 ratio. To ensure the groups do not become unbalanced the investigators will use stratified randomisation based on two factors: aphasia severity and time-since-stroke. The allocation will be balanced at each site and will be carried out by the Bangor Clinical Trials Unit.

INTERVENTIONS Experimental intervention (ICAP) As defined by the new framework commissioned by the NIHR and the MRC, ICAPs are complex interventions with multiple interacting components. The investigators 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.

PWA will be grouped into roughly-matched cohorts of 4 (based on aphasia severity). As 'day attenders' they will participate 09:00-17:00 for 4 days a week for 4 weeks, engaging for up to 6 hours a day. Some PWA will travel from home each day. Those who cannot manage this will stay 3 nights a week in a local hotel offering accessible rooms.

The aim is to provide ~100 hours of therapy. The content will involve patient and family education, individual goal-setting, impairment and activity-based therapy (language and communication), conversation-partner training, and facilitative strategies for communication. The interventions will be delivered using a variety of approaches, including individual and paired sessions, group sessions, independent practice (including therapy apps), and sessions with PWA and their family members.

The ICAP will also include a clinical psychology-led forum called Carers' Café to support nominated carers of PWA in adjusting and adapting to the changes they are experiencing. The group will meet weekly and follow the principles of Acceptance and Commitment Therapy. Themes will include 'letting go of the struggle', 'increasing mental flexibility', 'unhooking from the pain and loss', and acknowledging the strain that sometimes accompanies this role. During the ICAP, weekly 1-hour sessions will be held face-to-face where possible, or hybrid if not. The ICAP is an intensive experience for carers and they will need help in providing continued support for the PWA's recovery trajectory after discharge. Accordingly, 4 more weekly remote sessions of Carers' Café will be held following the ICAP to support ongoing adjustment and to establish a legacy of peer support.

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) the investigators will ensure the research team complete the relevant sections of the Client Service Receipt Inventory at each time point.

Inclusion Criteria:

1. Adult (>18 years old) PWA caused by stroke
2. More than 3 months post-stroke
3. Can use English to communicate (even if not as their first language)
4. Carers will be nominated (if available) by individual PWA

Exclusion Criteria:

1. Severe speech apraxia (no meaningful spoken word output)
2. Severe fatigue or other reasons they cannot commit to the timing and duration of the ICAP
3. Ongoing debilitating psychiatric disorders (e.g. psychosis, but not low mood)
4. Co-existing neurological disorders affecting engagement (e.g. dementia).

An anonymised data set will be made available for other researchers to request access to for perpetuity.