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

Palmer, Rebecca; Dimairo, Munyaradzi; Latimer, Nicholas; Cross, Elizabeth; Brady, Marian; Enderby, Pam; Bowen, Audrey; Julious, Steven; Harrison, Madeleine; Alshreef, Abualbishr; Bradley, Ellen; Bhadhuri, Arjun; Chater, Tim; Hughes, Helen; Witts, Helen; Herbert, Esther; Cooper, Cindy

Abstract

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?

Citation

Palmer, R., Dimairo, M., Latimer, N., Cross, E., Brady, M., Enderby, P., …Cooper, C. (2020). 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. Health Technology Assessment, 24(19), 1-176. https://doi.org/10.3310/hta24190

• Journal Article Type: Article
• Acceptance Date: Oct 1, 2019
• Online Publication Date: Apr 1, 2020
• Publication Date: Apr 1, 2020
• Deposit Date: May 2, 2020
• Publicly Available Date: May 5, 2020
• Journal: Health Technology Assessment
• Print ISSN: 1366-5278
• Electronic ISSN: 2046-4924
• Publisher: NIHR Journals Library
• Peer Reviewed: Peer Reviewed
• Volume: 24
• Issue: 19
• Pages: 1-176
• DOI: https://doi.org/10.3310/hta24190
• Public URL: https://nottingham-repository.worktribe.com/output/4373453
• Publisher URL: https://www.journalslibrary.nihr.ac.uk/hta/hta24190#/abstract
• Additional Information: Free to read: This content has been made freely available to all.; Contractual start date: 1-2014; Editorial review begun: 7-2018; Accepted for publication: 10-2019