Condition category
Circulatory System
Date applied
14/02/2014
Date assigned
27/03/2014
Last edited
27/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
Participants will be 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 does the study run from and for how long?
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.

Funding
Stroke Association (UK).

Main contact
Professor Glyn Humphreys
glyn.humphreys@psy.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Glyn Humphreys

ORCID ID

Contact details

Department of Experimental Psychology
Oxford University
South Parks Road
Oxford
OX1 3UD
United Kingdom
glyn.humphreys@psy.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol v2.0

Study information

Scientific title

A randomised controlled pilot study for developing and evaluating a care pathway for cognitive problems after stroke (the OCS-case project)

Acronym

OCS-care

Study hypothesis

That systematic screening for cognitive problems after stroke will improve outcome for patients and carers.

Ethics approval

NRES Committee West Midlands – Coventry & Warwickshire, 09/10/2012, REC reference: 12/WM/0335

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

'Not available in web format, please use the contact details below to request a patient information sheet'

Condition

Stroke

Intervention

Standard care arm only (within 2 months of stroke)
(i) 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)
(ii) 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.
(iii) 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)
(i) 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)
(ii) Barthel index
(iii) NIHSS

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2014

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Participants will be:
Stroke patients up to 90 years of age, plus their main carer.
Inclusion Criteria
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 only
1. Being the primary carer of stroke patient enrolled in the study
2. Willing and able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

The participant may not enter the study if ANY of the following apply:
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

Recruitment start date

01/03/2014

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Experimental Psychology
Oxford
OX1 3UD
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Research Services
Parks Road
Oxford
OX1 2UD
United Kingdom
heather.house@admin.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

Stroke Association (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes