Yes/No Questionnaire for Aphasic Patients (YNQ)

Stroke, Acute Clinical Trial

— YNQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257696
• Other study ID #: 2014/P03/031
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: February 21, 2019

Study information

• Verified date: June 2022
• Source: Groupe Hospitalier de la Rochelle Ré Aunis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aphasia
• Stroke
• Stroke, Acute

Intervention

Diagnostic Test:
• Close-ended questionnaire
Yes/no questionnaire used in order to identify "reliable respondent" and "unreliable respondent"

Locations

Country	Name	City	State
France	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Rochelle Ré Aunis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	measured within 7 in-hospital days