Cognitive Impairment - e.g. DementiaNCT02199782
Pilot Study of Cognitive Assessment in Welsh Speakers
A study testing Welsh language Cognitive Assessment in people with Cognitive Impairment - e.g. Dementia, run by Conor Martin at 1 site in United Kingdom.
Trial summary
19% of Wales' population speaks Welsh. Under the Welsh Language Act 1993, every public body providing services to the public in Wales has to prepare a scheme setting out how it will provide those services in Welsh. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment - e.g. Dementia
- What is being tested?
- Welsh language Cognitive Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2015to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Welsh Speakers - self-identify as first-language Welsh
- Diagnosis of Dementia - recorded in patient's case notes
Who cannot join
- Refusal
- Intercurrent illness
- Blind/any other disability which may prevent participant from fully completing Cognitive Assessment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Ysbyty Glan Clwyd
Bodelwyddan, Denbighshire, LL18 5UJ
Conor Martin, MBBCh, +447525931775, conor.martin@live.co.uk
Conor Martin, MBBCh
About this study
19% of Wales' population speaks Welsh. Under the Welsh Language Act 1993, every public body providing services to the public in Wales has to prepare a scheme setting out how it will provide those services in Welsh.
Diagnosing dementia requires a comprehensive assessment, an essential component of which is a cognitive assessment tool, which takes the form of a questionnaire. In clinical practice, this is currently only available through the medium of English.
Read more
The investigators objective is to measure the difference between Cognitive Assessment scores (using the Montreal cognitive assessment (MoCA)), when done in English and Welsh, in those who are cognitively impaired and whose first language is Welsh. The investigators predict that there will be a significant difference in scores in favour of the Welsh-medium tests, thus proving that the current mode of administering the test is prejudiced against patients whose first language is Welsh.
If the investigators predictions are correct, then the investigators would seek to introduce a validated Welsh-language cognitive assessment tool to the domain of the Welsh NHS.
- Conditions
- Cognitive Impairment - e.g. Dementia
- Being tested
- Welsh language Cognitive Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Welsh language Cognitive AssessmentOther
This intervention may intervene by displaying a more realisitic reflection of the patient's cognitive ability by assessing the patient in their first language
| Study group | Role | What they receive |
|---|---|---|
| Welsh | Active comparator | Participants will complete the cognitive assessment in Welsh and in English these will be compared to assess whether first language Welsh speakers perform better in Welsh. Receives: Other: Welsh language Cognitive Assessment |
| English | Active comparator | Participants will complete the cognitive assessment in Welsh and in English these will be compared to assess whether first language Welsh speakers perform better in Welsh. Receives: Other: Welsh language Cognitive Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Cognitive Assessment Score between Welsh and English
Measured: at 0 and 48 hrs
Secondary outcomes (1)
To measure the differences between participants' scores in Welsh and English and compare between different types of Dementia
We will records each participant's type of cognitive decline - e.g. Alzheimer's, Vascular, Frontal, Lewy Body, etc, and compare the differences in scores - to see whether different types of dementia will perform significantly worse or better in their first and second languages (Welsh and English).
Measured: 0 and 48hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startFeb 2015
- Primary completionAug 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cognitive Impairment - e.g. DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Conor Martin
- Sponsor type
- Other government
- Collaborators
- Betsi Cadwaladr University Health Board
- Responsible party
- Sponsor-investigator, Conor Martin, National Health Service, United Kingdom
- Investigators
- Sion Jones, MBBCh, Principal investigator, BCUHB NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02199782
- Sponsor's protocol ID
- BCUHB - PS - CAWS - 1
- Status last verified
- Jul 2014
- First submitted
- 15 Jul 2014
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cummings JL, Benson F, Hill MA, Read S. Aphasia in dementia of the Alzheimer type. Neurology. 1985 Mar;35(3):394-7. doi: 10.1212/wnl.35.3.394.
PubMed 3974897Mendez MF, Perryman KM, Ponton MO, Cummings JL. Bilingualism and dementia. J Neuropsychiatry Clin Neurosci. 1999 Summer;11(3):411-2. doi: 10.1176/jnp.11.3.411. No abstract available.
PubMed 10440021
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cognitive Assessment in Welsh Speakers
- ClinicalTrials.gov ID
- NCT02199782
- Acronym / sponsor ID
- BCUHB - PS - CAWS - 1
- Conditions
- Cognitive Impairment - e.g. Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Conor MartinOther government
- Collaborators
- Betsi Cadwaladr University Health Board
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
19% of Wales' population speaks Welsh. Under the Welsh Language Act 1993, every public body providing services to the public in Wales has to prepare a scheme setting out how it will provide those services in Welsh.
Diagnosing dementia requires a comprehensive assessment, an essential component of which is a cognitive assessment tool, which takes the form of a questionnaire. In clinical practice, this is currently only available through the medium of English.
The investigators objective is to measure the difference between Cognitive Assessment scores (using the Montreal cognitive assessment (MoCA)), when done in English and Welsh, in those who are cognitively impaired and whose first language is Welsh. The investigators predict that there will be a significant difference in scores in favour of the Welsh-medium tests, thus proving that the current mode of administering the test is prejudiced against patients whose first language is Welsh.
If the investigators predictions are correct, then the investigators would seek to introduce a validated Welsh-language cognitive assessment tool to the domain of the Welsh NHS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Welsh | Active comparator | Other: Welsh language Cognitive AssessmentParticipants will complete the cognitive assessment in Welsh and in English these will be compared to assess whether first language Welsh speakers perform better in Welsh. |
| English | Active comparator | Other: Welsh language Cognitive AssessmentParticipants will complete the cognitive assessment in Welsh and in English these will be compared to assess whether first language Welsh speakers perform better in Welsh. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Welsh Speakers - self-identify as first-language Welsh
- Diagnosis of Dementia - recorded in patient's case notes
Key exclusion criteria (3 listed)
- Refusal
- Intercurrent illness
- Blind/any other disability which may prevent participant from fully completing Cognitive Assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Welsh language Cognitive AssessmentThis intervention may intervene by displaying a more realisitic reflection of the patient's cognitive ability by assessing the patient in their first language | Other | English, Welsh |
Primary outcome
Difference in Cognitive Assessment Score between Welsh and English
Time frame: at 0 and 48 hrs
1 secondary outcome
To measure the differences between participants' scores in Welsh and English and compare between different types of Dementia
Time frame: 0 and 48hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Background: PubMed 3974897Cummings JL, Benson F, Hill MA, Read S. Aphasia in dementia of the Alzheimer type. Neurology. 1985 Mar;35(3):394-7. doi: 10.1212/wnl.35.3.394.
- Background: PubMed 10440021Mendez MF, Perryman KM, Ponton MO, Cummings JL. Bilingualism and dementia. J Neuropsychiatry Clin Neurosci. 1999 Summer;11(3):411-2. doi: 10.1176/jnp.11.3.411. No abstract available.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sion Jones, MBBCh principal investigator
BCUHB NHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Welsh language Cognitive Assessment in people with Cognitive Impairment - e.g. Dementia, run by Conor Martin at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Conor Martin, MBBCh (+447525931775, conor.martin@live.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Cognitive Assessment Score between Welsh and English (time frame: at 0 and 48 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02199782, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.