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ISRCTN
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ISRCTN91534629
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ClinicalTrials.gov identifier
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Public title
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Computer therapy versus usual stimulation for people with long standing aphasia
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Scientific title
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Evaluating the cost effectiveness of computer therapy compared with usual stimulation for people with long standing aphasia: a feasibility study [Previously known as Computerised Word Finding Therapy for Stroke]
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Acronym
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CACTUS
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Serial number at source
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7203
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Study hypothesis
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Aphasia is a communication disorder often caused by stroke. It can affect the ability to understand what is said, the ability to produce correct words and the ability to read and write. People with aphasia rarely receive treatment from NHS speech and language therapists for more than 3 months. It has been established that people with aphasia can continue to improve their communication with prolonged treatment (beyond 12 months). However this is rarely available. Surveys indicate that people with aphasia and their families often feel abandonned when therapy is discontinued and want to continue making efforts to improve (Stroke Survey 2006).
Step-by-Step is a computer program designed to help people to practise exercises to improve their ability to find the correct words when they are talking. This study aims to evaluate the feasibility of carrying out a large study to compare computer therapy with the usual stimulation provided for people with aphasia in stroke clubs or at home to see if use of computer software with assistance from a carer/volunteer can improve the ability of people with aphasia to talk. People who use the computers for treatment will be interviewed to find out how they found working with computers.
This research will test the methods for a randomised controlled trial to help establish whether people with 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 and in voluntary sector settings. Potential benefits to patients include the opportunity for continued treatment and thus improved ability to talk. It could also give patients independence and control over their therapy. The NHS would benefit by being able to support a long term aphasia treatment service without increasing demand on therapy resources.
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Lay summary
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Ethics approval
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NHS Bradford Research Ethics Committee approved on the 15th April 2009 (ref: 09/H1302/20)
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Study design
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Multicentre randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Community study
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Participants - inclusion criteria
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1. Diagnosis of stroke and aphasia with word finding difficulties as one of the predominant features as assessed by the Comprehensive Aphasia Test (CAT)
2. No longer receiving treatment from a speech and language therapist so that the computer treatment can be better isolated and evaluated
3. First stroke and reported by close relatives/friends to have had no speech or language difficulty pre-stroke to isolate cause
4. Both male and female 18 years or above with no upper age limit
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Participants - exclusion criteria
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Severe visual or cognitive difficulties reducing ability to use the computer program, tested by the ability to see and perform a simple, non-verbally based computer game.
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Anticipated start date
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30/10/2009
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Anticipated end date
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30/09/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 30; UK sample size: 30
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Interventions
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Thirty participants with aphasia will be recruited. Participants will be randomly allocated to computer treatment using Step-by-Step word finding software by Jane Mortley (group 1) or usual care (group 2). Group 1 will carry out computer exercises independent of a speech therapist for 5 months. Support will be provided only by stroke volunteers or carers. Structured interviews about the use of computers will be carried out with participants.
Study entry: single randomisation only
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Primary outcome measure(s)
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Recruitment rate, measured at baseline, 5 months and 8 months.
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Secondary outcome measure(s)
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Measured at baseline, 5 months and 8 months:
1. Acceptability of using computer based word finding therapy
2. Change in participation and wellbeing
3. Change in word retrieval
4. Estimation of effect size
5. Quality adjusted life years
6. Resource use data
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Sources of funding
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National Insititute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)
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Trial website
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Publications
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Contact name
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Dr
Rebecca
Palmer
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Address
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University of Sheffield
107 Innovation centre
217 Portobello
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City/town
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Sheffield
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Zip/Postcode
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S1 4DP
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Country
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United Kingdom
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Email
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r.l.palmer@sheffield.ac.uk
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Sponsor
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Sheffield Teaching Hospitals NHS Foundation Trust (UK)
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Address
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Royal Hallamshire Hospital
Glossop Road
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City/town
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Sheffield
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Zip/Postcode
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S10 2JF
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Country
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United Kingdom
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Sponsor website:
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http://www.sth.nhs.uk/
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Date applied
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21/05/2010
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Last edited
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08/11/2010
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Date ISRCTN assigned
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21/05/2010
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