Observational Study of the Evaluation of Post Traumatic Stress Post Stroke

NCT04299841 | Withdrawn

• 1 other identifier: 2019-A01962-55
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

PCL 5; Stroke

Outcome Measures

Primary Outcomes (1)

• Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 months after stroke

  Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 months after stroke. This evaluation will be made by completion of PCL-5 questionnaire (Post-traumatic stress disorder checklist version DSM-5 (DSM:Diagnostic and Statistical Manuel of Mental Disorders)). A PCL-5 positive score will be an indicator of post-traumatic stress disorder correlated with stroke.

  at time of inclusion (3 months after stroke)

Secondary Outcomes (6)

• Evaluate the number of patients managed for stroke and presenting Stroke Post Traumatic Disorder at 3 and at 6 months

  at time of inclusion (3 months after stroke) and 6 months after stroke (study participation duration for patient: 3 months)

• Evaluate the number of patients presenting a depressive state at 3 months

  at time of inclusion (3 months after stroke)

• Evaluate the number of patients under antidepressant or anxiolytics treatment before the stroke

  at time of inclusion (3 months after stroke)

• Evaluate the PCL-5 questionnaire as a screening tool of the stroke post traumatic disorder

  at time of inclusion (3 months after stroke) and 6 months after stroke (study participation duration for patient: 3 months)

• Evaluate the traumatic history of the patient before the occurrence of the stroke

  at time of inclusion (3 months after stroke)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ch Mont de Marsan: lead

Study Sites (1)

centre hospitalier Dax

Dax, 40100, France

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Stroke

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Harold PERDIGNON

  CH de Dax

  PRINCIPAL INVESTIGATOR

• Francine CLEMENTI, MD

  CH de Dax

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: March 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

FR (1)