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 |
| Secondary identifying numbers | 15733; HTA 12/21/01 |
- 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
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
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 |
|---|---|
| e.a.cross@sheffield.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 | 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 study start date | 01/01/2014 |
| Completion date | 12/09/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 285; UK Sample Size: 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
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
University/education
Research and Innovation Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
England
United Kingdom
"ROR" |
https://ror.org/05krs5044 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 10/07/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 27/01/2015 | Yes | No | |
| 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 |
| Other publications | impact for NHS SLT departments that participated in Big CACTUS | 07/12/2022 | 12/12/2022 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Qualitative exploration of the computerized speech and language therapy approach | 05/12/2023 | 07/12/2023 | Yes | No |
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.
