Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial.
Post-stroke aphasia might improve over many years with speech and language therapy; however speech and language therapy is often less readily available beyond a few months after stroke. We assessed self-managed computerised speech and language therapy (CSLT) as a means of providing more therapy than patients can access through usual care alone.
In this pragmatic, superiority, three-arm, individually randomised, single-blind, parallel group trial, patients were recruited from 21 speech and language therapy departments in the UK. Participants were aged 18 years or older and had been diagnosed with aphasia post-stroke at least 4 months before randomisation; they were excluded if they had another premorbid speech and language disorder caused by a neurological deficit other than stroke, required treatment in a language other than English, or if they were currently using computer-based word-finding speech therapy. Participants were randomly assigned (1:1:1) to either 6 months of usual care (usual care group), daily self-managed CSLT plus usual care (CSLT group), or attention control plus usual care (attention control group) with the use of computer-generated stratified blocked randomisation (randomly ordered blocks of sizes three and six, stratified by site and severity of word finding at baseline based on CAT Naming Objects test scores). Only the outcome assessors and trial statistician were masked to the treatment allocation. The speech and language therapists who were doing the outcome assessments were different from those informing participants about which group they were assigned to and from those delivering all interventions. The statistician responsible for generating the randomisation schedule was separate from those doing the analysis. Co-primary outcomes were the change in ability to retrieve personally relevant words in a picture naming test (with 10% mean difference in change considered a priori as clinically meaningful) and the change in functional communication ability measured by masked ratings of video-recorded conversations, with the use of Therapy Outcome Measures (TOMs), between baseline and 6 months after randomisation (with a standardised mean difference in change of 0·45 considered a priori as clinically meaningful). Primary analysis was based on the modified intention-to-treat (mITT) population, which included randomly assigned patients who gave informed consent and excluded those without 6-month outcome measures. Safety analysis included all participants. This trial has been completed and was registered with the ISRCTN, number ISRCTN68798818.
From Oct 20, 2014, to Aug 18, 2016, 818 patients were assessed for eligibility, of which 278 (34%) participants were randomly assigned (101 [36%] to the usual care group; 97 [35%] to the CSLT group; 80 [29%] to the attention control group). 86 patients in the usual care group, 83 in the CSLT group, and 71 in the attention control group contributed to the mITT. Mean word finding improvements were 1·1% (SD 11·2) in the usual care group, 16·4% (15·3) in the CSLT group, and 2·4% (8·8) in the attention control group. Word finding improvement was 16·2% (95% CI 12·7 to 19·6; p<0·0001) higher in the CSLT group than in the usual care group and was 14·4% (10·8 to 18·1) higher than in the attention control group. Mean changes in TOMs were 0·05 (SD 0·59) in the usual care group (n=84), 0·04 (0·58) in the CSLT group (n=81), and 0·10 (0·61) in the attention control group (n=68); the mean difference in change between the CSLT and usual care groups was -0·03 (-0·21 to 0·14; p=0·709) and between the CSLT and attention control groups was -0·01 (-0·20 to 0·18). The incidence of serious adverse events per year were rare with 0·23 events in the usual care group, 0·11 in the CSLT group, and 0·16 in the attention control group. 40 (89%) of 45 serious adverse events were unrelated to trial activity and the remaining five (11%) of 45 serious adverse events were classified as unlikely to be related to trial activity.
CSLT plus usual care resulted in a clinically significant improvement in personally relevant word finding but did not result in an improvement in conversation. Future studies should explore ways to generalise new vocabulary to conversation for patients with chronic aphasia post-stroke.
National Institute for Health Research, Tavistock Trust for Aphasia.
Palmer R
，Dimairo M
，Cooper C
，Enderby P
，Brady M
，Bowen A
，Latimer N
，Julious S
，Cross E
，Alshreef A
，Harrison M
，Bradley E
，Witts H
，Chater T
... -
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Factors Associated With Adherence to Self-Managed Aphasia Therapy Practice on a Computer-A Mixed Methods Study Alongside a Randomized Controlled Trial.
Background: Aphasia is a communication disorder often acquired after a stroke. Independent use of specialist aphasia software on a home computer is a form of asynchronous tele-rehabilitation that can provide increased opportunity for practice of rehabilitation exercises. This study aimed to explore the factors associated with adherence to self-managed aphasia computer therapy practice. Method: A mixed methods exploration of adherence was conducted alongside the Big CACTUS randomized controlled trial [ISRCTN: 68798818]. The trial evaluated the clinical effectiveness of self-managed aphasia computer therapy. This study reports secondary analysis of data from participants randomized to the computer therapy group to investigate whether any demographic, clinical or intervention variables were associated with adherence to therapy practice. A sub-sample of the same participants took part in qualitative interviews exploring the factors perceived to influence the amount of aphasia computer therapy practice undertaken. Interviews were analyzed thematically. A convergence-coding matrix was used to triangulate the two sets of findings. Results: Data from 85 participants randomized to the computer therapy group were included in the quantitative analyses. At a clinical level, a greater length of time post-stroke was associated with higher adherence to self-managed aphasia therapy practice on a computer. At an intervention level, length of computer therapy access and therapist time supporting the participant were associated with greater adherence to computer therapy practice. Interviews with 11 patients and 12 informal carers identified a multitude of factors perceived to influence engagement with tele-rehabilitation by people with aphasia. The factors grouped around three themes: capability to use the computer therapy, having the opportunity to practice (external influences and technological issues) and motivation (beliefs, goals and intentions vs. personality, emotions, habit and reinforcement). Triangulation demonstrated convergence for the finding that participants' practiced computer-based therapy exercises more when they received increased support from a speech and language therapist. Conclusion: Clinicians delivering asynchronous tele-rehabilitation involving self-management of aphasia therapy practice on a computer should consider the factors found to be associated with engagement when deciding which patients may be suited to this option, as well as how they can be supported to optimize the amount of practice they engage in.
Harrison M
，Palmer R
，Cooper C
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ResearchGate
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