Yes/No Questionnaire for Aphasic Patients (YNQ) (YNQ)

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

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.

Study Overview

Status

Completed

Conditions

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".

Study Type

Observational

Enrollment (Actual)

152

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • La Rochelle, France
        • Groupe Hospitalier de la Rochelle Ré Aunis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Right-handed, adult patients who are taken care in the neurovascular unit and in the neurology department because of a left stroke

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

measured within 7 in-hospital days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Aurélia RAVIER-CUETO, Groupe Hospitalier de la Rochelle Ré Aunis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 2, 2017

Primary Completion (ACTUAL)

February 21, 2019

Study Completion (ACTUAL)

February 21, 2019

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (ACTUAL)

August 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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