Trial Outcomes & Findings for Yes/No Questionnaire for Aphasic Patients (YNQ) (NCT NCT03257696)

NCT ID: NCT03257696

Last Updated: 2022-06-10

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

152 participants

Primary outcome timeframe

measured within 7 in-hospital days

Results posted on

2022-06-10

Participant Flow

Participant milestones

Participant milestones
Measure
Reliable
Patients who respond reliably to closed questions, according to the speech therapist classification
Unreliable
Patients who do not respond reliably to closed questions, according to the speech therapist classification
Overall Study
STARTED
123
29
Overall Study
COMPLETED
123
29
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Reliable
n=123 Participants
Patients who respond reliably to closed questions, according to the speech therapist classification
Unreliable
n=29 Participants
Patients who do not respond reliably to closed questions, according to the speech therapist classification
Total
n=152 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=123 Participants
0 Participants
n=29 Participants
0 Participants
n=152 Participants
Age, Categorical
Between 18 and 65 years
25 Participants
n=123 Participants
7 Participants
n=29 Participants
32 Participants
n=152 Participants
Age, Categorical
>=65 years
98 Participants
n=123 Participants
22 Participants
n=29 Participants
120 Participants
n=152 Participants
Age, Continuous
72.3 years
STANDARD_DEVIATION 12.8 • n=123 Participants
75.4 years
STANDARD_DEVIATION 14.7 • n=29 Participants
72.8 years
STANDARD_DEVIATION 13.2 • n=152 Participants
Sex: Female, Male
Female
57 Participants
n=123 Participants
17 Participants
n=29 Participants
74 Participants
n=152 Participants
Sex: Female, Male
Male
66 Participants
n=123 Participants
12 Participants
n=29 Participants
78 Participants
n=152 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
France
123 participants
n=123 Participants
29 participants
n=29 Participants
152 participants
n=152 Participants
Diagnostic
Ischemic stroke
109 Participants
n=123 Participants
24 Participants
n=29 Participants
133 Participants
n=152 Participants
Diagnostic
Hemorrhagic stroke
11 Participants
n=123 Participants
4 Participants
n=29 Participants
15 Participants
n=152 Participants
Diagnostic
Combination of both stroke subtypes
3 Participants
n=123 Participants
1 Participants
n=29 Participants
4 Participants
n=152 Participants
Thrombolysis
Thrombolysis
29 Participants
n=123 Participants
6 Participants
n=29 Participants
35 Participants
n=152 Participants
Thrombolysis
No thrombolysis
94 Participants
n=123 Participants
23 Participants
n=29 Participants
117 Participants
n=152 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Reliable
n=123 Participants
Patients who respond reliably to closed questions, according to the speech therapist classification
Unreliable
n=29 Participants
Patients who do not respond reliably to closed questions, according to the speech therapist classification
YNQ Score
YNQ score = 0
0 Participants
1 Participants
YNQ Score
YNQ score = 1
0 Participants
1 Participants
YNQ Score
YNQ score = 2
0 Participants
0 Participants
YNQ Score
YNQ score = 3
0 Participants
2 Participants
YNQ Score
YNQ score = 4
1 Participants
1 Participants
YNQ Score
YNQ score = 5
0 Participants
4 Participants
YNQ Score
YNQ score = 6
0 Participants
4 Participants
YNQ Score
YNQ score = 7
1 Participants
5 Participants
YNQ Score
YNQ score = 8
0 Participants
4 Participants
YNQ Score
YNQ score = 9
0 Participants
2 Participants
YNQ Score
YNQ score = 10
121 Participants
5 Participants

Adverse Events

Reliable

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Unreliable

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Camille Bonnin

Groupe Hospitalier de la Rochelle Ré Aunis

Phone: +0546455050

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place