Computerised speech and language therapy or attention control added to usual care for people with long-term post-stroke aphasia: the Big CACTUS three-arm RCT.

BACKGROUND

People with aphasia may improve their communication with speech and language therapy many months/years after stroke. However, NHS speech and language therapy reduces in availability over time post stroke.

OBJECTIVE

This trial evaluated the clinical effectiveness and cost-effectiveness of self-managed computerised speech and language therapy to provide additional therapy.

DESIGN

A pragmatic, superiority, single-blind, parallel-group, individually randomised (stratified block randomisation, stratified by word-finding severity and site) adjunct trial.

SETTING

Twenty-one UK NHS speech and language therapy departments.

PARTICIPANTS

People with post-stroke aphasia (diagnosed by a speech and language therapist) with long-standing (> 4 months) word-finding difficulties.

INTERVENTIONS

The groups were (1) usual care; (2) daily self-managed computerised word-finding therapy tailored by speech and language therapists and supported by volunteers/speech and language therapy assistants for 6 months plus usual care (computerised speech and language therapy); and (3) activity/attention control (completion of puzzles and receipt of telephone calls from a researcher for 6 months) plus usual care.

MAIN OUTCOME MEASURES

Co-primary outcomes - change in ability to find treated words of personal relevance in a bespoke naming test (impairment) and change in functional communication in conversation rated on the activity scale of the Therapy Outcome Measures (activity) 6 months after randomisation. A key secondary outcome was participant-rated perception of communication and quality of life using the Communication Outcomes After Stroke questionnaire at 6 months. Outcomes were assessed by speech and language therapists using standardised procedures. Cost-effectiveness was estimated using treatment costs and an accessible EuroQol-5 Dimensions, five-level version, measuring quality-adjusted life-years.

RESULTS

A total of 818 patients were assessed for eligibility and 278 participants were randomised between October 2014 and August 2016. A total of 240 participants (86 usual care, 83 computerised speech and language therapy, 71 attention control) contributed to modified intention-to-treat analysis at 6 months. The mean improvements in word-finding were 1.1% (standard deviation 11.2%) for usual care, 16.4% (standard deviation 15.3%) for computerised speech and language therapy and 2.4% (standard deviation 8.8%) for attention control. Computerised speech and language therapy improved word-finding 16.2% more than usual care did (95% confidence interval 12.7% to 19.6%;

LIMITATIONS

This trial excluded non-English-language speakers, the accessible EuroQol-5 Dimensions, five-level version, was not validated and the measurement of attention control fidelity was limited.

CONCLUSIONS

Computerised speech and language therapy enabled additional self-managed speech and language therapy, contributing to significant improvement in finding personally relevant words (as specifically targeted by computerised speech and language therapy) long term post stroke. Gains did not lead to improvements in conversation or quality of life. Cost-effectiveness is uncertain owing to uncertainty around the quality-adjusted life-year gain, but computerised speech and language therapy may be more cost-effective for participants with mild and moderate word-finding difficulties. Exploring ways of helping people with aphasia to use new words in functional communication contexts is a priority.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN68798818.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in

Aphasia is a communication disorder that can be caused by a stroke. It affects a person’s understanding of spoken words and their talking, reading and writing abilities. Communication may improve months, or years, after a stroke with speech and language therapy. Many patients want more speech and language therapy than the NHS can provide. The Big CACTUS (clinical and cost-effectiveness of aphasia computer treatment versus usual stimulation or attention control long term post-stroke) trial evaluated the use of speech and language therapy software for people with aphasia to practise finding words independently at home on their own computer or one loaned by the NHS. People with aphasia who had had a stroke at least 4 months previously were randomly allocated to one of three groups: usual speech and language therapy caredaily use of computerised speech and language therapy for 6 months, tailored by a speech and language therapist and supported by a volunteer or speech and language therapy assistantdaily completion of puzzles and supportive telephone calls from a researcher to mimic the activity/attention the computerised speech and language therapy group received. All groups received usual speech and language therapy. A total of 278 people with aphasia took part in this trial, from 21 UK NHS speech and language therapy departments. They had their strokes between 4 months and 36 years previously. Computerised speech and language therapy enabled more practice (28 hours on average) than usual speech and language therapy (3.8 hours). The computerised speech and language therapy group significantly improved their ability to say words they chose to practise compared with those in the usual speech and language therapy or puzzle book groups. Although computerised speech and language therapy can help people with aphasia to learn new words for years after stroke, no improvements in conversation or quality of life were seen. The cost-effectiveness for the NHS is still uncertain. However, our best estimate is that it is unlikely to be cost-effective for everyone with aphasia, but it may be cost-effective for people with mild and moderate word-finding difficulties. Next steps will focus on how to encourage use of new words in conversation to have an impact on quality of life.

Déclaration de conflit d'intérêts

All authors declare financial support from The Tavistock Trust for Aphasia. Rebecca Palmer was a National Institute for Health Research (NIHR)/Higher Education Funding Council for England-funded senior clinical academic lecturer until June 2017. She has current funding from the Stroke Association for a Doctor of Philosophy (PhD) student conducting work on fidelity to the intervention. The Stroke Association had previously funded early development work on the software used in the intervention but she was not involved in that. She was author of the intervention manual. Nicholas Latimer is supported by the NIHR (Post-doctoral Fellowship, reference PDF-2015-08-022) and is currently supported by Yorkshire Cancer Research (award S406NL). Pam Enderby has a patent on the Therapy Outcome Measures (2015) used in this trial from which she receives royalties. Audrey Bowen is funded by the Stroke Association and the NIHR Collaborations for Leadership in Applied Health Research and Care Greater Manchester. She co-authored the Communication Outcome after Stroke (COAST) and Carer COAST tools, which are patented. Madeleine Harrison receives PhD fellowship funding from the Stroke Association. Esther Herbert received a NIHR Research Methods Fellowship, outside the submitted work. Cindy Cooper sits on the NIHR Clinical Trials Unit (CTU) Standing Advisory Committee (2016 to present) and the UK Clinical Research Collaboration Registered CTU Network Executive Group (2015 to present).