NCT03257696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2019

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 10, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

1.4 years

First QC Date

August 18, 2017

Results QC Date

March 2, 2022

Last Update Submit

June 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 within 7 in-hospital days

Interventions

Yes/no questionnaire used in order to identify "reliable respondent" and "unreliable respondent"

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Over 18 years old
  • Left-sided stroke
  • Right-handed
  • Mother language: French
  • Hospitalized in neurovascular unit or neurology department
  • NIHSS score over 25

You may not qualify if:

  • Deaf
  • Psychiatric history
  • Stroke history
  • Dementia or pre-stroke cognitive impairment
  • Under guardianship
  • Refusal to participate (relatives)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Location

MeSH Terms

Conditions

StrokeAphasia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Camille Bonnin
Organization
Groupe Hospitalier de la Rochelle Ré Aunis

Study Officials

  • Aurélia RAVIER-CUETO

    Groupe Hospitalier de la Rochelle Ré Aunis

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2017

First Posted

August 22, 2017

Study Start

October 2, 2017

Primary Completion

February 21, 2019

Study Completion

February 21, 2019

Last Updated

June 10, 2022

Results First Posted

June 10, 2022

Record last verified: 2022-06

Locations