<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/NCT03257696</url>
  </required_header>
  <id_info>
    <org_study_id>2014/P03/031</org_study_id>
    <nct_id>NCT03257696</nct_id>
  </id_info>
  <brief_title>Yes/No Questionnaire for Aphasic Patients (YNQ)</brief_title>
  <acronym>YNQ</acronym>
  <official_title>Diagnostic Accuracy Study of an Answer Reliability Assessment Tool for Aphasic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier de la Rochelle Ré Aunis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier de la Rochelle Ré Aunis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Quality of care depends strongly on oral communication with patients. Stroke patients, who&#xD;
      have language disorders, have understanding difficulties, but also have difficulties in&#xD;
      expressing their needs and in being understood. Available tools do not allow a professional&#xD;
      consensus on the assessment of patients' ability to answer reliably to questions asked by&#xD;
      caregivers. The investigators propose an answer reliability assessment tool based on yes or&#xD;
      no questions. The goal of the present study is to define an optimal score for defining the&#xD;
      test positivity, as a compromise between sensitivity and specificity, and by emphasizing the&#xD;
      negative predictive value.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In France, about 130,000 persons per year are victims of stroke. Thirty percent of the&#xD;
      victims suffer from aphasia during the acute phase. These language impairments have an impact&#xD;
      on caregiving. In the context of post-stroke aphasia, the most relevant means of verbal&#xD;
      communication is closed-ended questioning. However, the available tools do not allow a&#xD;
      professional consensus and the comprehensive assessment tools for aphasia do not provide any&#xD;
      indication of the reliability of patients' answers. The investigators have developed a tool,&#xD;
      the yes/no questionnaire that consists of 10 closed-ended questions designed to assess the&#xD;
      patient's ability to provide a coherent answer. During one year, successive patients taken&#xD;
      care in the neurovascular unit at la Rochelle hospital will be assessed for eligibility to&#xD;
      the study and their relative will be informed and ask for consent. Aphasic patients will&#xD;
      therefore answer the yes/no questionnaire. Based on the speech therapist evaluation, patients&#xD;
      will be classified as &quot;reliable respondent&quot; or &quot;unreliable respondent&quot;.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">February 21, 2019</completion_date>
  <primary_completion_date type="Actual">February 21, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>YNQ Score</measure>
    <time_frame>measured within 7 in-hospital days</time_frame>
    <description>The Yes/No questionnaire consists in 10 closed-ended questions designed to assess the patient's ability to provide a coherent answer.&#xD;
It was designed with questions that are very easy to answer, with the following constraints:&#xD;
The questionnaire use only the auditory/verbal channel .&#xD;
The questions ask only about personal data because they are less ambiguous.&#xD;
The syntactical construction of the questions is very simple.&#xD;
Apart from the use of personal data very familiar to the participants, the other nouns in the closed questions are very frequent (according to a lexical database).&#xD;
The length of the questions was limited to seven words.&#xD;
With the exception of two questions, each yes-response question had a no-response equivalent, as in some existing tests.&#xD;
A score of zero indicates a wrong answer to all questions. A score of ten indicates a correct answer to all questions.</description>
  </primary_outcome>
  <enrollment type="Actual">152</enrollment>
  <condition>Stroke, Acute</condition>
  <condition>Aphasia</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Close-ended questionnaire</intervention_name>
    <description>Yes/no questionnaire used in order to identify &quot;reliable respondent&quot; and &quot;unreliable respondent&quot;</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Right-handed, adult patients who are taken care in the neurovascular unit and in the&#xD;
        neurology department because of a left stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years old&#xD;
&#xD;
          -  Left-sided stroke&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Mother language: French&#xD;
&#xD;
          -  Hospitalized in neurovascular unit or neurology department&#xD;
&#xD;
          -  NIHSS score over 25&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Deaf&#xD;
&#xD;
          -  Psychiatric history&#xD;
&#xD;
          -  Stroke history&#xD;
&#xD;
          -  Dementia or pre-stroke cognitive impairment&#xD;
&#xD;
          -  Under guardianship&#xD;
&#xD;
          -  Refusal to participate (relatives)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Aurélia RAVIER-CUETO</last_name>
    <role>Study Director</role>
    <affiliation>Groupe Hospitalier de la Rochelle Ré Aunis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier de la Rochelle Ré Aunis</name>
      <address>
        <city>La Rochelle</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>March 2, 2022</results_first_submitted>
  <results_first_submitted_qc>June 9, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">June 10, 2022</results_first_posted>
  <last_update_submitted>June 9, 2022</last_update_submitted>
  <last_update_submitted_qc>June 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aphasia</mesh_term>
    <mesh_term>Stroke</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03257696/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Reliable</title>
          <description>Patients who respond reliably to closed questions, according to the speech therapist classification</description>
        </group>
        <group group_id="P2">
          <title>Unreliable</title>
          <description>Patients who do not respond reliably to closed questions, according to the speech therapist classification</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="123"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reliable</title>
          <description>Patients who respond reliably to closed questions, according to the speech therapist classification</description>
        </group>
        <group group_id="B2">
          <title>Unreliable</title>
          <description>Patients who do not respond reliably to closed questions, according to the speech therapist classification</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="123"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="152"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.3" spread="12.8"/>
                    <measurement group_id="B2" value="75.4" spread="14.7"/>
                    <measurement group_id="B3" value="72.8" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diagnostic</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Ischemic stroke</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="133"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hemorrhagic stroke</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Combination of both stroke subtypes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Thrombolysis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="123"/>
                    <count group_id="B2" value="29"/>
                    <count group_id="B3" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Thrombolysis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No thrombolysis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>YNQ Score</title>
        <description>The Yes/No questionnaire consists in 10 closed-ended questions designed to assess the patient's ability to provide a coherent answer.&#xD;
It was designed with questions that are very easy to answer, with the following constraints:&#xD;
The questionnaire use only the auditory/verbal channel .&#xD;
The questions ask only about personal data because they are less ambiguous.&#xD;
The syntactical construction of the questions is very simple.&#xD;
Apart from the use of personal data very familiar to the participants, the other nouns in the closed questions are very frequent (according to a lexical database).&#xD;
The length of the questions was limited to seven words.&#xD;
With the exception of two questions, each yes-response question had a no-response equivalent, as in some existing tests.&#xD;
A score of zero indicates a wrong answer to all questions. A score of ten indicates a correct answer to all questions.</description>
        <time_frame>measured within 7 in-hospital days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Reliable</title>
            <description>Patients who respond reliably to closed questions, according to the speech therapist classification</description>
          </group>
          <group group_id="O2">
            <title>Unreliable</title>
            <description>Patients who do not respond reliably to closed questions, according to the speech therapist classification</description>
          </group>
        </group_list>
        <measure>
          <title>YNQ Score</title>
          <description>The Yes/No questionnaire consists in 10 closed-ended questions designed to assess the patient's ability to provide a coherent answer.&#xD;
It was designed with questions that are very easy to answer, with the following constraints:&#xD;
The questionnaire use only the auditory/verbal channel .&#xD;
The questions ask only about personal data because they are less ambiguous.&#xD;
The syntactical construction of the questions is very simple.&#xD;
Apart from the use of personal data very familiar to the participants, the other nouns in the closed questions are very frequent (according to a lexical database).&#xD;
The length of the questions was limited to seven words.&#xD;
With the exception of two questions, each yes-response question had a no-response equivalent, as in some existing tests.&#xD;
A score of zero indicates a wrong answer to all questions. A score of ten indicates a correct answer to all questions.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="123"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>YNQ score = 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 6</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 9</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>YNQ score = 10</title>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Reliable</title>
          <description>Patients who respond reliably to closed questions, according to the speech therapist classification</description>
        </group>
        <group group_id="E2">
          <title>Unreliable</title>
          <description>Patients who do not respond reliably to closed questions, according to the speech therapist classification</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="123"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Camille Bonnin</name_or_title>
      <organization>Groupe Hospitalier de la Rochelle Ré Aunis</organization>
      <phone>+0546455050</phone>
      <email>camille.bonnin@ght-atlantique17.fr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03257696
org study id: 2014/P03/031
nct id: NCT03257696
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Quality of care depends strongly on oral communication with patients. Stroke patients, who
      have language disorders, have understanding difficulties, but also have difficulties in
      expressing their needs and in being understood. Available tools do not allow a professional
      consensus on the assessment of patients' ability to answer reliably to questions asked by
      caregivers. The investigators propose an answer reliability assessment tool based on yes or
      no questions. The goal of the present study is to define an optimal score for defining the
      test positivity, as a compromise between sensitivity and specificity, and by emphasizing the
      negative predictive value.
In France, about 130,000 persons per year are victims of stroke. Thirty percent of the
      victims suffer from aphasia during the acute phase. These language impairments have an impact
      on caregiving. In the context of post-stroke aphasia, the most relevant means of verbal
      communication is closed-ended questioning. However, the available tools do not allow a
      professional consensus and the comprehensive assessment tools for aphasia do not provide any
      indication of the reliability of patients' answers. The investigators have developed a tool,
      the yes/no questionnaire that consists of 10 closed-ended questions designed to assess the
      patient's ability to provide a coherent answer. During one year, successive patients taken
      care in the neurovascular unit at la Rochelle hospital will be assessed for eligibility to
      the study and their relative will be informed and ask for consent. Aphasic patients will
      therefore answer the yes/no questionnaire. Based on the speech therapist evaluation, patients
      will be classified as "reliable respondent" or "unreliable respondent".
observational model: Case-Only
time perspective: Prospective
measure: YNQ Score
time frame: measured within 7 in-hospital days
description: The Yes/No questionnaire consists in 10 closed-ended questions designed to assess the patient's ability to provide a coherent answer.
It was designed with questions that are very easy to answer, with the following constraints:
The questionnaire use only the auditory/verbal channel .
The questions ask only about personal data because they are less ambiguous.
The syntactical construction of the questions is very simple.
Apart from the use of personal data very familiar to the participants, the other nouns in the closed questions are very frequent (according to a lexical database).
The length of the questions was limited to seven words.
With the exception of two questions, each yes-response question had a no-response equivalent, as in some existing tests.
A score of zero indicates a wrong answer to all questions. A score of ten indicates a correct answer to all questions.
intervention type: Diagnostic Test
intervention name: Close-ended questionnaire
description: Yes/no questionnaire used in order to identify "reliable respondent" and "unreliable respondent"
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Aurélia RAVIER-CUETO
role: Study Director
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
facility: 
country: France
responsible party type: Sponsor
mesh term: Aphasia
mesh term: Stroke
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 