Contact information
Type
Scientific
Primary contact
Dr Rebecca Palmer
ORCID ID
Contact details
University of Sheffield
107 Innovation centre
217 Portobello
Sheffield
S1 4DP
United Kingdom
r.l.palmer@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7203
Study information
Scientific title
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]
Acronym
CACTUS
Study hypothesis
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.
Ethics approval
NHS Bradford Research Ethics Committee approved on the 15th April 2009 (ref: 09/H1302/20)
Study design
Multicentre randomised interventional treatment trial
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: Rehabilitation; Disease: Community study
Intervention
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
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measures
Recruitment rate, measured at baseline, 5 months and 8 months.
Secondary outcome measures
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
Overall trial start date
30/10/2009
Overall trial end date
30/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 30; UK sample size: 30
Participant exclusion criteria
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.
Recruitment start date
30/10/2009
Recruitment end date
30/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Sheffield
Sheffield
S1 4DP
United Kingdom
Sponsor information
Organisation
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
Sponsor details
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
National Insititute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 resutls in http://www.ncbi.nlm.nih.gov/pubmed/22733794
Publication citations
-
Resutls
Palmer R, Enderby P, Cooper C, Latimer N, Julious S, Paterson G, Dimairo M, Dixon S, Mortley J, Hilton R, Delaney A, Hughes H, Computer therapy compared with usual care for people with long-standing aphasia poststroke: a pilot randomized controlled trial., Stroke, 2012, 43, 7, 1904-1911, doi: 10.1161/STROKEAHA.112.650671.