Oxford Cognitive Screen (OCS)-care: a study for developing and evaluating a care pathway for cognitive problems after stroke
| ISRCTN | ISRCTN50857950 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50857950 |
| Secondary identifying numbers | Protocol v2.0 |
- Submission date
- 14/02/2014
- Registration date
- 27/03/2014
- Last edited
- 12/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Cognitive problems (in memory, language, attention, action planning) can affect more than 90% of the stroke survivors, but currently there is no standardised care pathway to advise on the treatment of these problems and little evidence on whether diagnosis and advising on cognitive deficits improves outcome for survivors. The aim of this project is to assess whether a recently developed stroke-specific cognitive screen (the Oxford Cognitive Screen) can diagnose cognitive problems after stroke more accurately than competitor instruments, and whether this leads to improved outcome. This project builds on the recent completion of the Birmingham University Cognitive Screen trial (BUCS) by the research team, funded by the Stroke Association, which produced and validated a clinical screen (the Birmingham Cognitive Screen, BCoS) for cognitive problems in sub-acute stroke. The BCoS is more inclusive and less language-weighted than other screens, and gives a unique cognitive profile for survivors, predictive of longer-term outcomes. The Oxford Cognitive Screen (OCS, which will be used here, has been developed to cover similar ground but takes only 15 min to administer. The present study will ask whether initial data can be collected in order to assess whether there are contrasting outcomes for survivors who either (a) receive cognitive screening using the OCS and enter the proposed case pathway, or (b) are given assessment and treatment current in the NHS practice (e.g., screening using the Montreal Cognitive Screen, MOCA).
Who can participate?
Stroke patients up to 90 years of age, plus their main carer
What does the study involve?
Participants will be randomly allocated to one of two groups: standard care group or cognitive assessment group. There will be a number of tests/questionnaires.
Standard care arm group (within 2 months of stroke):
- MOCA: this is a 15min paper-and-pencil test currently used as a cognitive screening tool in dementia and as a short screen in acute stroke units (www.moca-test.org)
- Barthel index: this consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder.
- NIHSS: this is a questionnaire with 11 questions covering cognitive and motor problems after stroke. The questions cover motoric ability (including eye gaze), sensory deficits (including visual field tests), the presence of aphasia and neglect.
Cognitive assessment group (within 2 months of stroke):
- The OCS. This is a 15-min paper-and-pencil test that measures: attention and executive function, language, memory, praxis and number processing (see the Appendix for the Protocol)
- Barthel index
- NIHSS
All patients (at follow-up, 6 months post-initial assessment):
- OCS and MOCA
- Barthel index
- NIHSS
- Nottingham extended ADL (a 22 point scale assessing everyday activities)
- HADS (anxiety and depression measure)
- ICECAP (5 point scale assessing quality of life)
- Stroke Impact Scale
Carers (at the follow-up session):
- Carer strain index (a 13 point scale evaluating carer strains)
What are the possible benefits and risks of participating?
There are no known or potential risks. A benefit would occur if patients given a cognitive screen have better outcome. Patients entering the study will receive an assessment of their cognition and both they and their carer may benefit from this information which is currently not provided systematically. There are no side effects.
Where is the study run from?
The study is run from the University of Oxford but will have participating sites are the UK. Currently around 100 sites have expressed an interest.
When is the study starting and how long is it expected to run for?
The developmental phase of the study, establishing the OCS instrument, has been completed (started in January 2012). The study will now run from March 2014 until end of December 2015. Participants will be recruited throughout this period.
Who is funding the study?
Stroke Association (UK)
Who is the main contact?
Prof. Glyn Humphreys
glyn.humphreys@psy.ox.ac.uk
Contact information
Scientific
Department of Experimental Psychology
Oxford University
South Parks Road
Oxford
OX1 3UD
United Kingdom
| glyn.humphreys@psy.ox.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | 'Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled pilot study for developing and evaluating a care pathway for cognitive problems after stroke (the OCS-care project) |
| Study acronym | OCS-care |
| Study objectives | That systematic screening for cognitive problems after stroke will improve outcome for patients and carers. |
| Ethics approval(s) | NRES Committee West Midlands Coventry & Warwickshire, 09/10/2012, REC ref: 12/WM/0335 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | Standard care arm only (within 2 months of stroke): 1. MOCA. This is a 15min paper-and-pencil test currently used as a cognitive screening tool in dementia and as a short screen in acute stroke units (www.moca-test.org) 2. Barthel index The Barthel Index consists of 10 items that measure a person's daily functioning specifically the activities of daily living and mobility. The items include feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, continence of bowels and bladder. 3. NIHSS. This is a questionnaire with 11 questions covering cognitive and motor problems after stroke. The questions cover motoric ability (including eye gaze), sensory deficits (including visual field tests), the presence of aphasia and neglect. Cognitive assessment arm (within 2 months of stroke): 1. The OCS. This is a 15-min paper-and-pencil test that measures: attention and executive function, language, memory, praxis and number processing (see the Appendix for the Protocol) 2. Barthel index 3. NIHSS |
| Intervention type | Other |
| Primary outcome measure | NIHSS score measured at baseline, at 6 months post stroke |
| Secondary outcome measures | Oxford Cognitive Screen and the Montreal Cognitive Assessment measured at baseline, at 6 months post stroke |
| Overall study start date | 01/03/2014 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | Stroke patients up to 90 years of age, plus their main carer Patients: 1. Having had a stroke 2. Sufficient concentration to take part in paper and pencil tests for 1 hour (judged by the multi-disciplinary team in the hospital) 3. Sufficient language comprehension to pass the first orienting tests in the OCS. Within 2 months of the stroke 4. Male or female adults up to 90 years of age 5. Willing and sufficiently able to give informed consent to take part in the study Carers: 1. Being the primary carer of stroke patient enrolled in the study 2. Willing and able to give informed consent |
| Key exclusion criteria | 1. Too unwell to take part (judged by the multi-disciplinary team in the hospital) 2. Insufficient concentration to take part in paper and pencil tests for 1 hour (judged by the multi-disciplinary team in the hospital) 3. Insufficient language comprehension to pass the first comprehension tests in the OCS (picture pointing) 4. Outside of 2 months of the stroke |
| Date of first enrolment | 01/03/2014 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OX1 3UD
United Kingdom
Sponsor information
University/education
Research Services
Parks Road
Oxford
OX1 2UD
England
United Kingdom
| heather.house@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk/ |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
12/01/2018: No publications found, verifying study status with principal investigator.
