NCT03496480

Brief Summary

The primary aim of this retrospective cohort study is to test the hypothesis that previous traumatization (long) before an ischemic stroke increases the degree of stroke-induced PTSD symptoms at 9-13 months after the stroke event. Secondary outcome parameters include quality of life and depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
636

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

April 5, 2018

Last Update Submit

August 21, 2019

Conditions

Stroke

Keywords

ptsdstresstraumatization

Outcome Measures

Primary Outcomes (1)

  • Stroke-induced PTSD

    Stroke-induced PTSD will be measured using the Impact of Event Scale - Revised (IES-R).

    9-13 months after stroke

Secondary Outcomes (3)

  • Trauma exposure

    9-13 months after stroke

  • Lifetime PTSD

    9-13 months after stroke

  • Functional outcome

    9-13 months after stroke

Other Outcomes (1)

  • Depression

    9-13 months after stroke

Interventions

QuestionnairesDIAGNOSTIC_TEST

Psychological questionnaires: BTQ, IES-R, 7-items-short Screening scale, BDI, SF-36

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients treated at the Charité Medical Center for acute ischemic stroke (9-13 months after stroke)

You may qualify if:

  • Patients treated at the Charité Medical Center for acute ischemic stroke
  • Confirmation of diagnosis by CT or MRI
  • Age \> 18 years
  • Ability to give informed consent

You may not qualify if:

  • Stroke secondary to complications from an intracranial aneurysm, arterial-venous malformation, intracranial tumor or neoplastic process
  • Major diseases at the time of the hospital stay that would be expected to obviate meaningful follow-up assessments such as life-threatening heart or respiratory failure, renal or hepatic failure, cancer
  • \. Severe comprehension deficits, e.g. severe aphasia, dementia 3. Substantial pre-stroke disability (e.g. from a previous stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

StrokeStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
study doctor

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 12, 2018

Study Start

April 15, 2018

Primary Completion

February 1, 2019

Study Completion

July 1, 2019

Last Updated

August 22, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)