Intensive Comprehensive Aphasia Programme for People With Post-Stroke Aphasia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity College, London

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ICAP

    Behavioral

    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.

  • Standard Care (in control arm)

    Behavioral

    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.

Treatment groups

334 Participants
are divided into 2 treatment groups
Group A: Intensive Comprehensive Aphasia ProgrammeExperimental treatment 1 intervention
Group B: Control (standard care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stroke and Aphasia Quality of Life Scale-39

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

Time frame
Four months post allocation to interventio or control arm.
2

Structural MRI brain scan

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.

Time frame
Four months post treatment-allocation

Secondary outcomes

1

Comprehensive Aphasia Test

Language impairment: this test is scalar and tests multiple language domains: speech production, auditory comprehension, reading and writing. Higher score = better performance. Raw scores are transformed into T-Scores to compare across domains. Min score is 25 and max score is 75.

Time frame
Baseline, 1-month, 4-month and 9-month post treatment-allocation
2

Communicative Effectiveness Index

Functional Communication: The Communicative Effectiveness Index is a 16-item questionnaire designed to assess the functional communication abilities of people with aphasia, typically rated by carers on a 10-cm visual analogue scale (0-100 mm) for each item. Maximum and Minimum Scores Minimum Score (Lowest Performance): 0, indicating "not able at all". Maximum Score (Best Performance): 100

Time frame
Baseline, 4-month and 9-month post treatment-allocation
3

Communicative Participation Item Bank

Confidence measure: For the 10-item Communicative Participation Item Bank (CPIB) General Short Form, the raw summary scores range from 0 to 30. Key scoring details for the 10-item short form: Minimum Score (0): Indicates maximum interference in communication participation (most severe restriction). Maximum Score (30): Indicates no interference in communication participation (no restriction). Scoring System: "Not at all" = 3, "A little" = 2, "Quite a bit" = 1, "Very much" = 0.

Time frame
Baseline, 1-month, 4-month and 9-month post treatment-allocation
4

Stroke Aphasic Depression Questionnaire

Measure of mood: The Stroke Aphasic Depression Questionnaire (SADQ) Minimum Score: 0 Maximum Score: 63 Description: 21 items completed by a caregiver, with higher scores indicating higher levels of depression.

Time frame
Baseline, 4-month and 9-month post treatment-allocation

Other outcomes

Sponsors and contacts

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University College, London

Lead sponsor

St George's University Hospitals NHS Foundation Trust

Collaborator

University College London Hospitals

Collaborator

City, University of London

Collaborator

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