<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02199782</url>
  </required_header>
  <id_info>
    <org_study_id>BCUHB - PS - CAWS - 1</org_study_id>
    <nct_id>NCT02199782</nct_id>
  </id_info>
  <brief_title>Pilot Study of Cognitive Assessment in Welsh Speakers</brief_title>
  <official_title>Pilot Study of Cognitive Assessment in Welsh Speakers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Conor Martin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Betsi Cadwaladr University Health Board</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Health Service, United Kingdom</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      19% of Wales' population speaks Welsh. Under the Welsh Language Act 1993, every public body&#xD;
      providing services to the public in Wales has to prepare a scheme setting out how it will&#xD;
      provide those services in Welsh.&#xD;
&#xD;
      Diagnosing dementia requires a comprehensive assessment, an essential component of which is a&#xD;
      cognitive assessment tool, which takes the form of a questionnaire. In clinical practice,&#xD;
      this is currently only available through the medium of English.&#xD;
&#xD;
      The investigators objective is to measure the difference between Cognitive Assessment scores&#xD;
      (using the Montreal cognitive assessment (MoCA)), when done in English and Welsh, in those&#xD;
      who are cognitively impaired and whose first language is Welsh. The investigators predict&#xD;
      that there will be a significant difference in scores in favour of the Welsh-medium tests,&#xD;
      thus proving that the current mode of administering the test is prejudiced against patients&#xD;
      whose first language is Welsh.&#xD;
&#xD;
      If the investigators predictions are correct, then the investigators would seek to introduce&#xD;
      a validated Welsh-language cognitive assessment tool to the domain of the Welsh NHS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">October 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Cognitive Assessment Score between Welsh and English</measure>
    <time_frame>at 0 and 48 hrs</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To measure the differences between participants' scores in Welsh and English and compare between different types of Dementia</measure>
    <time_frame>0 and 48hrs</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cognitive Impairment - e.g. Dementia</condition>
  <arm_group>
    <arm_group_label>Welsh</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>English</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Welsh language Cognitive Assessment</intervention_name>
    <description>This intervention may intervene by displaying a more realisitic reflection of the patient's cognitive ability by assessing the patient in their first language</description>
    <arm_group_label>English</arm_group_label>
    <arm_group_label>Welsh</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Welsh Speakers - self-identify as first-language Welsh&#xD;
&#xD;
          -  Diagnosis of Dementia - recorded in patient's case notes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal&#xD;
&#xD;
          -  Intercurrent illness&#xD;
&#xD;
          -  Blind/any other disability which may prevent participant from fully completing&#xD;
             Cognitive Assessment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sion Jones, MBBCh</last_name>
    <role>Principal Investigator</role>
    <affiliation>BCUHB NHS</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Conor Martin, MBBCh</last_name>
    <phone>+447525931775</phone>
    <email>conor.martin@live.co.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ysbyty Glan Clwyd</name>
      <address>
        <city>Bodelwyddan</city>
        <state>Denbighshire</state>
        <zip>LL18 5UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Conor Martin, MBBCh</last_name>
      <phone>+447525931775</phone>
      <email>conor.martin@live.co.uk</email>
    </contact>
    <investigator>
      <last_name>Conor Martin, MBBCh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>3974897</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10440021</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>July 23, 2014</last_update_submitted>
  <last_update_submitted_qc>July 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Health Service, United Kingdom</investigator_affiliation>
    <investigator_full_name>Conor Martin</investigator_full_name>
    <investigator_title>Dr Conor Martin</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02199782
org study id: BCUHB - PS - CAWS - 1
nct id: NCT02199782
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Difference in Cognitive Assessment Score between Welsh and English
time frame: at 0 and 48 hrs
measure: To measure the differences between participants' scores in Welsh and English and compare between different types of Dementia
time frame: 0 and 48hrs
description: 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).
arm group label: Welsh
arm group type: Active Comparator
description: 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.
arm group label: English
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Welsh language Cognitive Assessment
description: This intervention may intervene by displaying a more realisitic reflection of the patient's cognitive ability by assessing the patient in their first language
arm group label: English
arm group label: Welsh
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sion Jones, MBBCh
role: Principal Investigator
affiliation: BCUHB NHS
last name: Conor Martin, MBBCh
phone: +447525931775
email: conor.martin@live.co.uk
facility: 
contact: 
investigator: 
country: United Kingdom
citation: 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: 3974897
citation: 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: 10440021
responsible party type: Sponsor-Investigator
investigator affiliation: National Health Service, United Kingdom
investigator full name: Conor Martin
investigator title: Dr Conor Martin
mesh term: Dementia
mesh term: Cognitive Dysfunction