Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multi-centre single-blinded, randomised controlled trial

Rebecca Palmer, Munyaradzi Dimairo , Cindy Cooper, Pam Enderby, Marian Brady, Audrey Bowen, Nicholas Latimer, Steven Julious, Elizabeth Cross, Abualbishr Alshreef , Madeleine Harrison, E Bradley , Helen Witts , Tim Chater

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Abstract

BACKGROUND: 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.

METHODS: 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.

FINDINGS: 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.

INTERPRETATION: 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.

FUNDING: National Institute for Health Research, Tavistock Trust for Aphasia.

Original languageEnglish
Pages (from-to)821-833
Number of pages13
JournalLancet Neurology
Volume18
Issue number9
Early online date7 Aug 2019
DOIs
Publication statusPublished - Sep 2019

Fingerprint

Language Therapy
Speech Therapy
Aphasia
Randomized Controlled Trials
Stroke
Control Groups
Random Allocation
Outcome Assessment (Health Care)
Aptitude
Language
Language Disorders
Therapeutics
Speech Disorders
Vocabulary

Keywords

  • Post-stroke aphasia
  • speech therapy
  • language therapy
  • CSLT
  • self-managed computerised speech

Cite this

Palmer, Rebecca ; Dimairo , Munyaradzi ; Cooper, Cindy ; Enderby, Pam ; Brady, Marian ; Bowen, Audrey ; Latimer, Nicholas ; Julious, Steven ; Cross, Elizabeth ; Alshreef , Abualbishr ; Harrison, Madeleine ; Bradley , E ; Witts , Helen ; Chater, Tim. / Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multi-centre single-blinded, randomised controlled trial. In: Lancet Neurology. 2019 ; Vol. 18, No. 9. pp. 821-833.
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author = "Rebecca Palmer and Munyaradzi Dimairo and Cindy Cooper and Pam Enderby and Marian Brady and Audrey Bowen and Nicholas Latimer and Steven Julious and Elizabeth Cross and Abualbishr Alshreef and Madeleine Harrison and E Bradley and Helen Witts and Tim Chater",
note = "Acceptance and AAM requested 10/5/19 ET and 24/5/19 Unable to validate until at least one of these. ^Update: validated as acceptance date from Manchester repository (see https://www.research.manchester.ac.uk/portal/en/publications/selfmanaged-computerised-speech-and-language-therapy-for-patients-with-chronic-aphasia-poststroke-compared-to-usual-care-or-attention-control-big-cactus(a6023328-5792-4aca-8ed3-c30bd75a9ed7).html) ET 3/6/19 ^^VoR uploaded, OA 2/9/19",
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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 2019, 'Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multi-centre single-blinded, randomised controlled trial', Lancet Neurology, vol. 18, no. 9, pp. 821-833. https://doi.org/10.1016/S1474-4422(19)30192-9

Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multi-centre single-blinded, randomised controlled trial. / Palmer, Rebecca; Dimairo , Munyaradzi; Cooper, Cindy; Enderby, Pam; Brady, Marian; Bowen, Audrey; Latimer, Nicholas; Julious, Steven; Cross, Elizabeth; Alshreef , Abualbishr; Harrison, Madeleine; Bradley , E; Witts , Helen; Chater, Tim.

In: Lancet Neurology, Vol. 18, No. 9, 09.2019, p. 821-833.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multi-centre single-blinded, randomised controlled trial

AU - Palmer, Rebecca

AU - Dimairo , Munyaradzi

AU - Cooper, Cindy

AU - Enderby, Pam

AU - Brady, Marian

AU - Bowen, Audrey

AU - Latimer, Nicholas

AU - Julious, Steven

AU - Cross, Elizabeth

AU - Alshreef , Abualbishr

AU - Harrison, Madeleine

AU - Bradley , E

AU - Witts , Helen

AU - Chater, Tim

N1 - Acceptance and AAM requested 10/5/19 ET and 24/5/19 Unable to validate until at least one of these. ^Update: validated as acceptance date from Manchester repository (see https://www.research.manchester.ac.uk/portal/en/publications/selfmanaged-computerised-speech-and-language-therapy-for-patients-with-chronic-aphasia-poststroke-compared-to-usual-care-or-attention-control-big-cactus(a6023328-5792-4aca-8ed3-c30bd75a9ed7).html) ET 3/6/19 ^^VoR uploaded, OA 2/9/19

PY - 2019/9

Y1 - 2019/9

N2 - BACKGROUND: 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.METHODS: 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.FINDINGS: 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.INTERPRETATION: 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.FUNDING: National Institute for Health Research, Tavistock Trust for Aphasia.

AB - BACKGROUND: 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.METHODS: 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.FINDINGS: 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.INTERPRETATION: 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.FUNDING: National Institute for Health Research, Tavistock Trust for Aphasia.

KW - Post-stroke aphasia

KW - speech therapy

KW - language therapy

KW - CSLT

KW - self-managed computerised speech

U2 - 10.1016/S1474-4422(19)30192-9

DO - 10.1016/S1474-4422(19)30192-9

M3 - Article

C2 - 31397288

VL - 18

SP - 821

EP - 833

JO - Lancet Neurology

JF - Lancet Neurology

SN - 1474-4422

IS - 9

ER -