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Yes/No Questionnaire for Aphasic Patients (YNQ)

Diagnostic Accuracy Study of an Answer Reliability Assessment Tool for Aphasic Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03257696
Acronym
YNQ
Enrollment
152
Registered
2017-08-22
Start date
2017-10-02
Completion date
2019-02-21
Last updated
2022-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Stroke, Acute

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTClose-ended questionnaire

Yes/no questionnaire used in order to identify reliable respondent and unreliable respondent

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Over 18 years old * Left-sided stroke * Right-handed * Mother language: French * Hospitalized in neurovascular unit or neurology department * NIHSS score over 25

Exclusion criteria

* Deaf * Psychiatric history * Stroke history * Dementia or pre-stroke cognitive impairment * Under guardianship * Refusal to participate (relatives)

Design outcomes

Primary

MeasureTime frameDescription
YNQ Scoremeasured within 7 in-hospital daysThe 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.

Countries

France

Participant flow

Participants by arm

ArmCount
Reliable
Patients who respond reliably to closed questions, according to the speech therapist classification
123
Unreliable
Patients who do not respond reliably to closed questions, according to the speech therapist classification
29
Total152

Baseline characteristics

CharacteristicReliableUnreliableTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
98 Participants22 Participants120 Participants
Age, Categorical
Between 18 and 65 years
25 Participants7 Participants32 Participants
Age, Continuous72.3 years
STANDARD_DEVIATION 12.8
75.4 years
STANDARD_DEVIATION 14.7
72.8 years
STANDARD_DEVIATION 13.2
Diagnostic
Combination of both stroke subtypes
3 Participants1 Participants4 Participants
Diagnostic
Hemorrhagic stroke
11 Participants4 Participants15 Participants
Diagnostic
Ischemic stroke
109 Participants24 Participants133 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
France
123 participants29 participants152 participants
Sex: Female, Male
Female
57 Participants17 Participants74 Participants
Sex: Female, Male
Male
66 Participants12 Participants78 Participants
Thrombolysis
No thrombolysis
94 Participants23 Participants117 Participants
Thrombolysis
Thrombolysis
29 Participants6 Participants35 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1230 / 29
other
Total, other adverse events
0 / 1230 / 29
serious
Total, serious adverse events
0 / 1230 / 29

Outcome results

Primary

YNQ Score

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.

Time frame: measured within 7 in-hospital days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
ReliableYNQ ScoreYNQ score = 30 Participants
ReliableYNQ ScoreYNQ score = 60 Participants
ReliableYNQ ScoreYNQ score = 20 Participants
ReliableYNQ ScoreYNQ score = 41 Participants
ReliableYNQ ScoreYNQ score = 71 Participants
ReliableYNQ ScoreYNQ score = 10 Participants
ReliableYNQ ScoreYNQ score = 80 Participants
ReliableYNQ ScoreYNQ score = 90 Participants
ReliableYNQ ScoreYNQ score = 50 Participants
ReliableYNQ ScoreYNQ score = 10121 Participants
ReliableYNQ ScoreYNQ score = 00 Participants
UnreliableYNQ ScoreYNQ score = 105 Participants
UnreliableYNQ ScoreYNQ score = 01 Participants
UnreliableYNQ ScoreYNQ score = 11 Participants
UnreliableYNQ ScoreYNQ score = 20 Participants
UnreliableYNQ ScoreYNQ score = 32 Participants
UnreliableYNQ ScoreYNQ score = 41 Participants
UnreliableYNQ ScoreYNQ score = 54 Participants
UnreliableYNQ ScoreYNQ score = 84 Participants
UnreliableYNQ ScoreYNQ score = 64 Participants
UnreliableYNQ ScoreYNQ score = 75 Participants
UnreliableYNQ ScoreYNQ score = 92 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026