Yes/No Questionnaire for Aphasic Patients (YNQ)

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.

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Key information

Conditions

Stroke, Acute Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

About this study

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".

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Close-ended questionnaire

Diagnostic Test

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

Primary outcomes

YNQ Score

Time frame: measured within 7 in-hospital days
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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Registry information

Official study title

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

Acronym: YNQ

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Aug 22, 2017
Registry last updated: Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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