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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.
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".
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Close-ended questionnaire | Diagnostic Test | Yes/no questionnaire used in order to identify "reliable respondent" and "unreliable respondent" |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
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Inclusion Criteria:
Exclusion Criteria:
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Right-handed, adult patients who are taken care in the neurovascular unit and in the neurology department because of a left stroke
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| Name | Affiliation | Role |
|---|---|---|
| Aurélia RAVIER-CUETO | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier de la Rochelle Ré Aunis | La Rochelle | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reliable | Patients who respond reliably to closed questions, according to the speech therapist classification |
| FG001 | Unreliable | Patients who do not respond reliably to closed questions, according to the speech therapist classification |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reliable | Patients who respond reliably to closed questions, according to the speech therapist classification |
| BG001 | Unreliable | Patients who do not respond reliably to closed questions, according to the speech therapist classification |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
A score of zero indicates a wrong answer to all questions. A score of ten indicates a correct answer to all questions. | Posted | Count of Participants | Participants | measured within 7 in-hospital days |
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reliable | Patients who respond reliably to closed questions, according to the speech therapist classification |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Camille Bonnin | Groupe Hospitalier de la Rochelle Ré Aunis | +0546455050 | camille.bonnin@ght-atlantique17.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2017 | Feb 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001037 | Aphasia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnostic | Count of Participants | Participants |
|
| Thrombolysis | Count of Participants | Participants |
|
Patients who respond reliably to closed questions, according to the speech therapist classification |
| OG001 | Unreliable | Patients who do not respond reliably to closed questions, according to the speech therapist classification |
|
|
| 0 |
| 123 |
| 0 |
| 123 |
| 0 |
| 123 |
| EG001 | Unreliable | Patients who do not respond reliably to closed questions, according to the speech therapist classification | 0 | 29 | 0 | 29 | 0 | 29 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Combination of both stroke subtypes |
|