- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03257696
Yes/No Questionnaire for Aphasic Patients (YNQ) (YNQ)
June 9, 2022 updated by: Groupe Hospitalier de la Rochelle Ré Aunis
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
Intervention / Treatment
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:
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/P03/031
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.
Clinical Trials on Aphasia
-
University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Aphasia | Stroke, Ischemic | Aphasia, Broca | Aphasia, Anomic | Aphasia, Global | Aphasia, Fluent | Aphasia, Mixed | Aphasia, Jargon | Aphasia, Expressive | Aphasia, ConductionUnited States
-
University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
-
Institute for Bioengineering of CataloniaHospital Universitari Joan XXIII de Tarragona.; Universitat Pompeu FabraCompletedAphasia | Aphasia, Broca | Aphasia, Wernicke | Aphasia, Fluent | Aphasia, NonfluentSpain
-
Flint Rehabilitation Devices, LLCUniversity of TexasCompleted
-
Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
-
University of California, BerkeleyUniversity of California, San Francisco; California State University, East Bay and other collaboratorsRecruitingAphasia | Aphasia, Acquired | Aphasia Non Fluent | Aphasia, FluentUnited States
-
Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
-
Montreal Heart InstituteActive, not recruitingNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
-
University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
Clinical Trials on Close-ended questionnaire
-
University Health Network, TorontoNot yet recruitingDiabetes | Diabetic Foot | Amputation | Lower Limb Wound
-
Weill Medical College of Cornell UniversityCompletedAngioplasty PatientsUnited States
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH) and other collaboratorsCompletedObstructive Sleep Apnea | Down SyndromeUnited States
-
Weill Medical College of Cornell UniversityCompletedHypertensionUnited States
-
Weill Medical College of Cornell UniversityCompleted
-
Cornell UniversityRecruitingPain ThresholdUnited States
-
AZ Sint-Jan AVCompletedAtrial FibrillationBelgium
-
Stanford UniversitySurgSolutions, LLCCompleted
-
Region StockholmKarolinska Institutet; Linkoeping University; Stockholm UniversityRecruitingPregnancy | Primary Health Care | Youth | Interpersonal ViolenceSweden
-
University of California, San DiegoCalifornia Department of Public Health; Community Beyond Violence; Sierra Community... and other collaboratorsEnrolling by invitationSexual Violence | Adolescent Behavior | Sexual AssaultUnited States