1. Technology to the rescue: A pilot RCT to examine the impact of computerised therapy for long-standing aphasia R Palmer, P Enderby, G Paterson, NIHR CLAHRC for South Yorkshire

2. Speech & Language Therapy to improve language ability is often limited beyond first few months post stroke Growing evidence that improvement can continue long term Problem: Intensity of treatment required to achieve improvements in chronic phase would increase demands on often limited SLT resources Need to investigate flexible and cost effective means of service delivery to this group Background

3. Approach to long term self managed computer treatment 1. Light touch speech therapy input –Assessment –Tailoring schedule of word finding exercises (targeted, personalised) using StepbyStep© software 2. Self managed regular practice –Client to practise exercises independently –Minimum of 20 mins 3 times a week 3. Volunteer support –Carer/relative/volunteer assistance with practical management of the hardware/software –Encourage use of new vocabulary (‘use it or lose it’)

4. CACTUS Cost effectiveness of aphasia computer therapy versus usual stimulation (funded by NIHR RfPB programme) Single blinded, pragmatic parallel-group, RCT design StepbyStep © approach using computer software for word finding for 5 months versus usual stimulation Pilot study

5. QuestionMeasure Feasible?Recruitment rate Ability to practice independently Ability to offer a volunteer Effective?Difference in change in % words named correctly at 5 months from baseline between groups Cost effective? Incremental cost effectiveness ratio (ICER) EQ5D  QALYs Diaries  resource use Acceptable?Semi-structured interviews

6. Eligibility Inclusion criteria: 6 months post stroke Aphasia No longer receiving SLT impairment based treatment Exclusion criteria: Cognitive or visual difficulties

7. Procedure Baseline assessments Randomisation computer treatment 5 months usual stimulation 5 months. Month 8 Outcome measures repeated to assess for treatment maintenance Month 5 Outcome measures (blinded)

8. Feasible to carry out trial? 89.3% interested in receiving self managed word finding treatment with a computer Recruited 34 participants in 12months (2 areas of UK) – 1.2 per month Over 75% of participants completed 5 month outcome measures.

9. Feasible to deliver intervention? 11/15 participants completing the treatment practiced at least 20 minutes 3 times a week for 5 months 11/15 had the offer of volunteer support 25 hours Independent practice

10. Effective? 0 20 40 60 80 100 All treated words (%) 058 Follow-up (Months) No computer group 0 20 40 60 80 100 All treated words ( %) 058 Follow-up (Months) Computer group Computer group improved naming by 19.8% (ITT) more than control group 5 months from baseline Statistically significant at the 5% level of significance (P=0.014, confidence interval 4.4% – 35.2%)

11. Cost effective? Per person treated Costs (over life time) QALYsIncremental costs Incremental QALYs ICER (incremental cost effectiveness ratio) Control group£18,6873.07 Treatment group£19,1563.22£4690.15£3127 The intervention would represent a cost effective use of resources as the ICER threshold is usually £20,000 per additional QALY gained (in the UK). Uncertainties: relapse rate, changes over time in patients who are not treated

12. Acceptable? 14 participants & 10 carers interviewed Main themes Self managed computer therapy Disadvantages Comparison with face to face SLT Benefits Help and support

13. Benefits CONFIDENCE ‘her confidence is more and she can say things without being frightened of saying the wrong thing’ WORD FINDING ‘She knows what she wants to say but it can be difficult to get it out but she has improved since doing that program’ SENTENCES ‘She’s had her stroke 30 years and she’s never strung a sentence together. It was quite nice when she said ‘what have you been doing?’ INDEPENDENCE ‘a lot of the time P would sit and do it himself and I didn’t have to be stood by him.’ GENERALISATION ‘I like...avocado please [mimed pointing to object]’ REPETITION ‘there’s repetition which gets things in better than just you know, like an hour a week or something with a Speech Therapist’ PERSONALISATION ‘There was certain input into what was on it [the program] from her about places that she liked’ Clinical outcomesComputer therapy process

14. Disadvantages Clinical outcomes Computer Therapy Process FATIGUE ‘ I think probably sometimes a computer can make you feel ill... feel very fatigued... Linda [wife] always says no more than 20 minutes‘ NO IMPROVEMENT ‘he just tends to stick to same words. He doesn’t tend to say much more’ TIME ‘we were trying to do it 5 or 6 nights a week, which, if I am honest, was quite time consuming for us’ Proportion of comments about advantages far greater than those about disadvantages

15. Clinical implications Potential for self managed practice with a computer and volunteer support to be clinically effective for people with aphasia long term post stroke Based on results of small study, would expect it to be cost effective Generally acceptable to patients and carers Volunteers play an important role in supporting self managed practice Things to consider: severity, fatigue, time available for practice

16. Future direction of CACTUS Local Implementation CACTi Extension of current service provision in Sheffield Evaluation of new service  business case Adequately powered study ‘Big CACTUS’ Pilot showed feasibility Promising results

17. This presentation presents independent research commissioned by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-1207-14097). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. This study was part funded and supported by the Stroke and Telehealth themes of the South Yorkshire Collaboration for Leadership in applied health research and care (CLAHRC) We also wish to thank: – Collaborators at University of Sheffield: Cindy Cooper, Simon Dixon, Steven Julious, Nick Latimer – Sheffield Teaching Hospitals – Newcastle & North Tyneside NHS Trust – Barnsley & Rotherham SLT departments – Speakability – The Stroke Association – The Stroke Research Network – Steps Consulting Ltd – Jane and Peter Mortley – All the volunteers Acknowledgements