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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02199782
Other study ID # BCUHB - PS - CAWS - 1
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 15, 2014
Last updated July 23, 2014
Start date February 2015
Est. completion date October 2015

Study information

Verified date July 2014
Source National Health Service, United Kingdom
Contact Conor Martin, MBBCh
Phone +447525931775
Email conor.martin@live.co.uk
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2015
Est. primary completion date August 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Welsh Speakers - self-identify as first-language Welsh

- Diagnosis of Dementia - recorded in patient's case notes

Exclusion Criteria:

- Refusal

- Intercurrent illness

- Blind/any other disability which may prevent participant from fully completing Cognitive Assessment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Welsh language Cognitive Assessment
This intervention may intervene by displaying a more realisitic reflection of the patient's cognitive ability by assessing the patient in their first language

Locations

Country Name City State
United Kingdom Ysbyty Glan Clwyd Bodelwyddan Denbighshire

Sponsors (2)

Lead Sponsor Collaborator
Conor Martin Betsi Cadwaladr University Health Board

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Cummings JL, Benson F, Hill MA, Read S. Aphasia in dementia of the Alzheimer type. Neurology. 1985 Mar;35(3):394-7. — View Citation

Mendez MF, Perryman KM, Pontón MO, Cummings JL. Bilingualism and dementia. J Neuropsychiatry Clin Neurosci. 1999 Summer;11(3):411-2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in Cognitive Assessment Score between Welsh and English at 0 and 48 hrs No
Secondary 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). 0 and 48hrs No