NCT02199782

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

July 24, 2014

Status Verified

July 1, 2014

Enrollment Period

6 months

First QC Date

July 15, 2014

Last Update Submit

July 23, 2014

Conditions

Cognitive Impairment - e.g. Dementia

Outcome Measures

Primary Outcomes (1)

  • Difference in Cognitive Assessment Score between Welsh and English

    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

    0 and 48hrs

Study Arms (2)

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.

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.

Other: Welsh language Cognitive Assessment

Interventions

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

EnglishWelsh

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Welsh Speakers - self-identify as first-language Welsh
  • Diagnosis of Dementia - recorded in patient's case notes

You may not qualify if:

  • Refusal
  • Intercurrent illness
  • Blind/any other disability which may prevent participant from fully completing Cognitive Assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ysbyty Glan Clwyd

Bodelwyddan, Denbighshire, LL18 5UJ, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 3974897BACKGROUND

  • Mendez 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.

    PMID: 10440021BACKGROUND

Study Officials

  • Sion Jones, MBBCh

    BCUHB NHS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Conor Martin, MBBCh

CONTACT

+447525931775conor.martin@live.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Conor Martin

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 24, 2014

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

July 24, 2014

Record last verified: 2014-07

Locations

GB(1)