Clinical trial NCT03257696: Yes/No Questionnaire for Aphasic Patients (YNQ)
Official title: Diagnostic Accuracy Study of an Answer Reliability Assessment Tool for Aphasic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Aphasia
Lead sponsor: Groupe Hospitalier de la Rochelle Ré Aunis
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief 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.

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".

Eligibility criteria: 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)

Primary outcomes:
measure: YNQ Score
timeFrame: measured within 7 in-hospital days
Secondary outcomes:
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Groupe Hospitalier de la Rochelle Ré Aunis
Study officials:
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
name: Aurélia RAVIER-CUETO
role: STUDY_DIRECTOR
References: