Stroke, AcuteYNQNCT03257696
Yes/No Questionnaire for Aphasic Patients (YNQ)
An observational study of Stroke, Acute and Aphasia, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Aphasia
- What is being tested?
- Close-ended questionnaire
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2017to 21 Feb 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Right-handed, adult patients who are taken care in the neurovascular unit and in the neurology department because of a left stroke
Who may be able to join
- Over 18 years old
- Left-sided stroke
- Right-handed
- Mother language: French
- Hospitalized in neurovascular unit or neurology department
- NIHSS score over 25
Who cannot join
- Deaf
- Psychiatric history
- Stroke history
- Dementia or pre-stroke cognitive impairment
- Under guardianship
- Refusal to participate (relatives)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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".
- Conditions
- Stroke, Acute, Aphasia
- Being tested
- Close-ended questionnaire
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Close-ended questionnaireDiagnostic test
Yes/no questionnaire used in order to identify "reliable respondent" and "unreliable respondent"
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured within 7 in-hospital days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start2 Oct 2017
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélia RAVIER-CUETO, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257696
- Sponsor's protocol ID
- 2014/P03/031
- Acronym
- YNQ
- Status last verified
- Jun 2022
- First submitted
- 18 Aug 2017
- Last updated
- 10 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy Study of an Answer Reliability Assessment Tool for Aphasic Patients
- ClinicalTrials.gov ID
- NCT03257696
- Acronym / sponsor ID
- YNQ / 2014/P03/031
- Conditions
- Stroke, Acute, Aphasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 10 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Right-handed, adult patients who are taken care in the neurovascular unit and in the neurology department because of a left stroke
Key inclusion criteria (6 listed)
- Over 18 years old
- Left-sided stroke
- Right-handed
- Mother language: French
- Hospitalized in neurovascular unit or neurology department
Key exclusion criteria (6 listed)
- Deaf
- Psychiatric history
- Stroke history
- Dementia or pre-stroke cognitive impairment
- Under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Close-ended questionnaireYes/no questionnaire used in order to identify "reliable respondent" and "unreliable respondent" | Diagnostic test | – |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélia RAVIER-CUETO study director
Groupe Hospitalier de la Rochelle Ré Aunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Aphasia, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YNQ Score (time frame: measured within 7 in-hospital days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.