Plain English Summary
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 June 2018
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
Trial website
http://www.sheffield.ac.uk/scharr/sections/dts/ctru/bigcactus
Contact information
Type
Scientific
Primary contact
Mrs Elizabeth Cross
ORCID ID
http://orcid.org/0000-0002-7976-8463
Contact details
Sheffield Clinical Trials Research Unit
School of Health and Related Research (ScHARR)
University of Sheffield
30 Regent Street
Sheffield
S1 4DA
United Kingdom
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e.a.cross@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15733; HTA 12/21/01
Study information
Scientific title
Cost effectiveness of Aphasia Computer Treatment versus Usual Stimulation or attention control long term post stroke: a randomised trial
Acronym
Big CACTUS
Study hypothesis
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
Leeds West REC, 13/01/2014, ref: 13/YH/0377
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/01/2014
Overall trial end date
30/06/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 285; UK Sample Size: 285
Participant 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
Recruitment start date
01/09/2014
Recruitment end date
18/08/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Teaching Hospitals NHS Foundation Trust
S10 2JF
Trial participating centre
Humber NHS Foundation Trust
HU10 6ED
Trial participating centre
Newcastle Upon Tyne Hospitals NHS Foundation Trust
NE7 7DN
Trial participating centre
Northern Health & Social Care Trust
BT41 2RL
Trial participating centre
Belfast Health & Social Care Trust
BT9 7AB
Trial participating centre
South Essex Partnership University NHS Foundation Trust
SS11 7XX
Trial participating centre
NHS Greater Glasgow and Clyde
G12 0XH
Trial participating centre
Cwm Taf University Health Board
CF45 4SN
Trial participating centre
Derbyshire Community Health Services NHS Trust
DE45 1AD
Trial participating centre
Nottinghamshire Healthcare NHS Trust
NG3 6AA
Trial participating centre
Northern Lincolnshire & Goole NHS Foundation Trust "
DN15 7BH
Trial participating centre
Livewell Southwest (Plymouth Community Healthcare)
PL4 7PY
Trial participating centre
Norfolk Community Health and Care NHS Trust
NR2 3TU
Trial participating centre
Somerset Partnership NHS Foundation Trust
TA6 4RN
Trial participating centre
Cambridgeshire and Peterborough NHS Foundation Trust
CB21 5EF
Trial participating centre
Northamptonshire Healthcare Foundation Trust
NN15 7PW
Trial participating centre
Dorset HealthCare University Foundation Trust
BH17 0RB
Trial participating centre
City Hospitals Sunderland NHS Foundation Trust
SR4 7TP
Trial participating centre
Abertawe Bro Morgannwg University Health Board (ABMUHB)
SA12 7BR
Trial participating centre
NHS Ayrshire and Arran
KA6 6AB
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Results will be disseminated in June 2018. Publication in a high impact peer reviewed journal planned for 2018/19.
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.
Intention to publish date
01/01/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25623162