Clinical trial NCT04299841: Observational Study of the Evaluation of Post Traumatic Stress Post Stroke
Official title: Stress Disorder Post-stroke: Observational Study of the Evaluation of Post Traumatic Stress Post Stroke (Stroke Post Traumatic Disorder)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Post Traumatic Stress Disorder
Keywords: PCL 5
Stroke
Lead sponsor: Ch Mont de Marsan
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who was hospitalized with a diagnosis of stroke in the neurology department and oriented to the post-stroke consultation (3 months after the hospital discharge) or un the follow-up care and readaptation department of hospital center of Dax or Mont de Marsan

Brief summary: This prospective, observational, multicentre study evaluates the existence of Post-traumatic stress disorder following a stroke at 3 and 6 months after the management of the patient.

Questionnaires will be used to assess the presence of stroke post traumatic disorder.

The evaluation of stroke post traumatic disorder would allow to underline the importance of the awareness of the care teams in the the screening of these disorders and to evaluate if the Post-traumatic Stress Disorder Checklist Scale (PCL5) is an effective screening tool.


Eligibility criteria: Inclusion Criteria:

* Patient age \> 18years old
* Patient registered with a social security scheme
* Patient who was given a written information and who gave his/her non-opposition
* Patient who was hospitalized with a diagnosis of stroke in the neurology department and oriented to the post-stroke consultation (3 months after the hospital discharge) or un the follow-up care and readaptation department of hospital center of Dax or Mont de Marsan

Exclusion Criteria:

* Patient with a serious disability sequelae (mRS\>3),
* Patient without enough level of proficiency in the French language,
* Patient with neurocognitive and neurocognitive disorder diagnosed,
* Patient with history of significant psychiatric disorders diagnosed,
* Patient with seve aphasia

Primary outcomes:
measure: Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 months after stroke
timeFrame: at time of inclusion (3 months after stroke)
Secondary outcomes:
measure: Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 and at 6 months
timeFrame: at time of inclusion (3 months after stroke) and 6 months after stroke (study participation duration for patient: 3 months)
measure: Evaluate the number of patients presenting a depressive state at 3 months
timeFrame: at time of inclusion (3 months after stroke)
measure: Evaluate the number of patients under antidepressant or anxiolytics treatment before the stroke
timeFrame: at time of inclusion (3 months after stroke)
measure: Evaluate the PCL-5 questionnaire as a screening tool of the stroke post traumatic disorder
timeFrame: at time of inclusion (3 months after stroke) and 6 months after stroke (study participation duration for patient: 3 months)
measure: Evaluate the traumatic history of the patient before the occurrence of the stroke
timeFrame: at time of inclusion (3 months after stroke)
measure: Evaluate the existence of a peritraumatic dissociation at the time of the occurrence of the stroke
timeFrame: at time of inclusion (3 months after stroke)
Other outcomes:
Locations:
city: Dax
country: France
facility: centre hospitalier Dax
Study officials:
affiliation: CH de Dax
name: Harold PERDIGNON
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Dax
name: Francine CLEMENTI, MD
role: STUDY_DIRECTOR
References: