Cost effectiveness of Aphasia Computer Treatment versus Usual Stimulation or attention control long term post stroke

ISRCTN	ISRCTN68798818
DOI	https://doi.org/10.1186/ISRCTN68798818
Protocol serial number	15733; HTA 12/21/01
Sponsor	University of Sheffield (UK)
Funder	Health Technology Assessment Programme

Submission date: 18/02/2014
Registration date: 18/02/2014
Last edited: 07/12/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Aphasia is a language disorder affecting understanding, talking, reading and writing, often as a result of a stroke. People with aphasia rarely receive speech and language therapy for more than a few months after a stroke. They may receive continued support from stroke groups and carers or relatives. There is evidence that people can continue to improve their language skills for several years. There is also evidence that people with aphasia can use computer software independently for structured language practice. This study investigates whether people who have had aphasia for more than 4 months can get better at finding the correct words by using computer exercises, and whether offering computer therapy is good value for money.

Who can participate?
Those identified as having had a stroke, with a diagnosis of aphasia, 4 months or more after the stroke, aged 18 years or above.

What does the study involve?
A Research Speech and Language Therapist (SLT) will visit potential participants at home to assess their language and daily life activities. The SLT will use a consent support tool to identify the style of information the potential participant is most likely to understand to be able to give informed consent. For those with severe aphasia the researcher will seek advice from a carer, relative or legal representative about whether or not the potential participant should take part. Participants will be randomly allocated to one of the following three groups:
1. Continuing with usual activities/therapy
2. Using the computer therapy exercises
3. Carrying out daily puzzle book activities
Usual care will involve a range of activities as this varies across the country, such as face to face speech and language therapy support, or attendance at support groups. The computer therapy will be tailored to the individuals' needs by an SLT, using a computer program specifically designed to help people with aphasia improve their word finding ability, called StepByStep. Participants will be encouraged to practice daily, and trained volunteers or SLT assistants will provide support with language practice and computer use. Participants allocated to do puzzle book activities will be provided with books of standard puzzles to be carried out each day. A member of the research team will contact the participants or carers once a month to mimic the attention provided by volunteers in the computer therapy arm. Participants will be in the study for 12 months and have their treatment for 6 months, with follow-up assessments at 6, 9 and 12 months.

What are the possible benefits and risks of participating?
The initial study showed greater ability to find words and have a conversation, and improved confidence. The only risk identified was fatigue (tiredness). Participants will have the opportunity to keep the software on their own computer at the end of the study. The SLT will help those that did not receive the computer treatment during the study to borrow a computer and software at the end of the study.

Where is the study run from?
Participants will be recruited from about 20 speech and language therapy departments across the UK, from current and past patient records and contacts with longer-term voluntary support groups.

When is the study starting and how long is it expected to run for?
January 2014 to September 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mrs Liz Cross
e.a.cross@sheffield.ac.uk

Contact information

Mrs Elizabeth Cross
Scientific

Sheffield Clinical Trials Research Unit
School of Health and Related Research (ScHARR)
University of Sheffield
30 Regent Street
Sheffield
S1 4DA
United Kingdom

ORCID ID	0000-0002-7976-8463
Email	e.a.cross@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Cost effectiveness of Aphasia Computer Treatment versus Usual Stimulation or attention control long term post stroke: a randomised trial
Study acronym	Big CACTUS
Study objectives	This research will establish whether people with post stroke 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.
Ethics approval(s)	Leeds West REC, 13/01/2014, ref: 13/YH/0377
Health condition(s) or problem(s) studied	Topic: Stroke Research Network; Subtopic: Primary Care, Rehabilitation; Disease: Therapy type
Intervention	Participants will be randomly allocated to either: 1. Continuing with usual activities/therapy only 2. Using the computer therapy exercises with usual care 3. Carrying out daily puzzle book activities with usual care
Intervention type	Other
Primary outcome measure(s)	Current primary outcome measures as of 20/02/2018: 1. The change in word finding ability of words personally relevant to the participant will be measured by a picture naming task (100 words with a maximum of 2 points each). The word finding score will be expressed as a percentage of the total score and change in the percentage 6 months from baseline will be calculated 2. Improvement in functional communication will be measured by blinded ratings of video recorded conversations between a SLT and participants, using the activity scale of the Therapy Outcome Measures Added 18/04/2018: The outcomes are measured at 6, 9 and 12 months. Previous primary outcome measures: 1. The change in the number of words (of personal relevance to the participant) named correctly at 6 months will be measured by a picture naming task 2. Improvement in functional communication will be measured by blinded ratings of video recorded conversations between a SLT and participants using the activity scale of the Therapy Outcome Measures and number of target words used in conversation, at 6 months
Key secondary outcome measure(s)	Current secondary outcome measures as of 20/02/2018: 1. Improvement in patient perception of communication will be measured using the COAST - a patient reported measure of communication participation and related quality of life 2. Use of learnt vocabulary in the context of conversation will be measured using a checklist of target words during rating of the videoed conversations at 6 months Added 18/04/2018: The outcomes are measured at 6, 9 and 12 months. Previous secondary outcome measures: Improvement in patient perception of communication will be measured using the COAST - a patient-reported measure of communication participation and related quality of life
Completion date	12/09/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	285
Total final enrolment	278
Key inclusion criteria	1. Aged 18 or over 2. Diagnosis of stroke(s) 3. Onset of stroke at least 4 months prior to randomisation 4. Diagnosis of aphasia, subsequent to stroke, as confirmed by a trained speech and language therapist. 5. Word retrieval difficulties tested by the naming test of the Comprehensive Aphasia Test [25] (score of 10-90% 5-43/48). 6. Ability to perform a simple matching task with the StepbyStep© programme (to confirm sufficient vision and cognitive ability to participate in the intervention)
Key exclusion criteria	1. They have another premorbid speech and language disorder caused by a neurological deficit other than stroke (a formal diagnosis can be reported by the participant or relatives and confirmed by the recruiting speech and language therapist). 2. They are unable to repeat words (suggesting presence of severe dyspraxia) 3. They require treatment for a language other than English (as the software is in English) 4. They are currently using the StepbyStep© computer programme or other computer speech therapy aimed at word retrieval/naming
Date of first enrolment	01/09/2014
Date of final enrolment	18/08/2016

Locations

Countries of recruitment

United Kingdom
England
Northern Ireland
Scotland
Wales

Study participating centres

Sheffield Teaching Hospitals NHS Foundation Trust

S10 2JF
United Kingdom

Humber NHS Foundation Trust

HU10 6ED
United Kingdom

Newcastle Upon Tyne Hospitals NHS Foundation Trust

NE7 7DN
United Kingdom

Northern Health & Social Care Trust

BT41 2RL
United Kingdom

Belfast Health & Social Care Trust

BT9 7AB
United Kingdom

South Essex Partnership University NHS Foundation Trust

SS11 7XX
United Kingdom

NHS Greater Glasgow and Clyde

G12 0XH
United Kingdom

Cwm Taf University Health Board

CF45 4SN
United Kingdom

Derbyshire Community Health Services NHS Trust

DE45 1AD
United Kingdom

Nottinghamshire Healthcare NHS Trust

NG3 6AA
United Kingdom

Northern Lincolnshire & Goole NHS Foundation Trust "

DN15 7BH
United Kingdom

Livewell Southwest (Plymouth Community Healthcare)

PL4 7PY
United Kingdom

Norfolk Community Health and Care NHS Trust

NR2 3TU
United Kingdom

Somerset Partnership NHS Foundation Trust

TA6 4RN
United Kingdom

Cambridgeshire and Peterborough NHS Foundation Trust

CB21 5EF
United Kingdom

Northamptonshire Healthcare Foundation Trust

NN15 7PW
United Kingdom

Dorset HealthCare University Foundation Trust

BH17 0RB
United Kingdom

City Hospitals Sunderland NHS Foundation Trust

SR4 7TP
United Kingdom

Abertawe Bro Morgannwg University Health Board (ABMUHB)

SA12 7BR
United Kingdom

NHS Ayrshire and Arran

KA6 6AB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Current IPD sharing statement as of 14/06/2019: All data requests should be submitted to the corresponding author for consideration. Please note exclusive use will be retained until the publication of major outputs. Access to anonymised data may be granted following review. Previous IPD sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from Rebecca Palmer (r.l.palmer@sheffield.ac.uk). All data collected (anonymised) will become available after publication of the report and main peer reviewed paper in 2018 for 10 years from the end of study date. The trialists would individually consider each request before deciding whether to give which (if any) data. They would ensure secure transfer of information and stipulate terms of use of the data within a data sharing agreement. They have consented participants to anonymised data sharing. Shared data would always be anonymised as far as possible.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2019	12/08/2019	Yes	No
Results article	results	01/04/2020	06/05/2020	Yes	No
Results article	results	23/11/2020	18/12/2020	Yes	No
Protocol article	protocol	27/01/2015		Yes	No
HRA research summary			28/06/2023	No	No
Other publications	impact for NHS SLT departments that participated in Big CACTUS	07/12/2022	12/12/2022	Yes	No
Other publications	Qualitative exploration of the computerized speech and language therapy approach	05/12/2023	07/12/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/12/2023: Publication reference added.
12/12/2022: Publication reference added.
22/10/2021: Internal review.
18/12/2020: Publication reference added.
06/08/2020: The overall trial end date was changed from 30/06/2018 to 12/09/2017.
06/05/2020: Publication reference added.
12/08/2019: Publication reference and total final enrolment added.
14/06/2019: The following changes were made to the trial record:
1. The intention to publish date was changed from 01/01/2019 to 10/07/2019.
2. The IPD sharing statement was changed.
18/04/2018: Outcome measures timepoints and IPD sharing statement added.
20/02/2018: The primary and secondary outcome measures and the publication and dissemination plan were updated.
29/03/2017: The overall trial start date was changed from 01/09/2014 to 01/01/2014.
16/08/2016: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2016 to 18/08/2016.
2. The overall trial end date was changed from 30/04/2016 to 30/06/2018.