Computerised aphasia therapy RCT (Big CACTUS)
Research type
Research Study
Full title
Cost effectiveness of aphasia computer treatment versus usual stimulation or attention control long term post stroke (Big CACTUS)
IRAS ID
138568
Contact name
Rebecca Palmer
Contact email
Sponsor organisation
University of Sheffield
ISRCTN Number
ISRCTN68798818
Research summary
Aphasia is a communication disorder often caused by stroke. It can affect the ability to understand what is said, the ability to produce correct words and the ability to read and write. People with aphasia rarely receive treatment from NHS speech and language therapists for more than 3 months. It has been established that people with aphasia can continue to improve their communication with prolonged treatment (beyond 12 months). However this is rarely available. Surveys indicate that people with aphasia and their families often feel abandoned when therapy is discontinued and want to continue making efforts to improve (Stroke Survey 2006). Step-by-Step is a computer program designed to help people to practise exercises to improve their ability to find the correct words when they are talking. Following a successful pilot, this study aims to compare computer therapy with attention control (puzzle books) and usual care to see if use of computer software with assistance from a volunteer/speech therapy assistant can improve the ability of people with aphasia to talk. This research will establish whether people with aphasia can continue to improve their ability to talk after completion of traditional NHS therapy, and whether this can be achieved cost effectively by offering computer treatment at home. Potential benefits to patients include the opportunity for continued treatment and thus improved ability to talk. It could also give patients independence and control over their therapy. The NHS would benefit by being able to support a long term aphasia treatment services without increasing demand on therapy resources.
Lay Summary of Results:
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%; p < 0.0001) and 14.4% more than attention control did (95% confidence interval 10.8% to 18.1%). Most of this effect was maintained at 12 months (n = 219); the mean differences in change in word-finding score were 12.7% (95% confidence interval 8.7% to 16.7%) higher in the computerised speech and language therapy group (n = 74) than in the usual-care group (n = 84) and 9.3% (95% confidence interval 4.8% to 13.7%) higher in the computerised speech and language therapy group than in the attention control group (n = 61). Computerised speech and language therapy did not show significant improvements on the Therapy Outcome Measures or Communication Outcomes After Stroke scale compared with usual care or attention control. Primary cost-effectiveness analysis estimated an incremental cost per participant of £732.73 (95% credible interval £674.23 to £798.05). The incremental quality-adjusted life-year gain was 0.017 for computerised speech and language therapy compared with usual care, but its direction was uncertain (95% credible interval –0.05 to 0.10), resulting in an incremental cost-effectiveness ratio of £42,686 per quality-adjusted life-year gained. For mild and moderate word-finding difficulty subgroups, incremental cost-effectiveness ratios were £22,371 and £28,898 per quality-adjusted life-year gained, respectively, for computerised speech and language therapy compared with usual care.
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.Has the registry been updated to include summary results?: Yes
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Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
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Have participants been informed of the results of the study?: Pending
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Have you enabled sharing of study data with others?: No
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Have you enabled sharing of tissue samples and associated data with others?: Yes
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Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0377
Date of REC Opinion
13 Jan 2014
REC opinion
Favourable Opinion