Condition category
Circulatory System
Date applied
18/02/2014
Date assigned
18/02/2014
Last edited
16/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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.

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?
The study is due to start recruiting from September 2014, over an 18-month period. 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.

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

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
-
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.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/122101
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/113946/PRO-12-21-01.pdf

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 below 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
3. Carrying out daily puzzle book activities

Intervention type

Other

Phase

Phase III

Drug names

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

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

01/09/2014

Overall trial end date

30/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be included if:
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

Participants will be excluded from the study if:
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

University of Sheffield
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

University of Sheffield (UK)

Sponsor details

Research and Innovation Services
New Spring House
231 Glossop Road
Sheffield
S10 2GW
United Kingdom

Sponsor type

University/education

Website

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

Not provided at time of registration

Intention to publish date

01/01/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25623162

Publication citations

Additional files

Editorial Notes

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.