Stroke Clinical Trial
Official title:
How to Identify Fatigue in Stroke Patients: Validity of the Post-stroke Fatigue Case Definition
Verified date | January 2017 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will translate an English case definition of poststroke fatigue and validate it against the Multidimensional Fatigue Questionnaire-20 and the Fatigue Severity Scale
Status | Completed |
Enrollment | 70 |
Est. completion date | March 2015 |
Est. primary completion date | March 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Patients with a clinical stroke within the last 6 months as judged by a senior doctor or by the research assistant. Patients that have given written informed consent Exclusion Criteria: Patients with aphasia, dementia or cognitive deficits so severe that they are unable to understand the purpose of the interview and the questionnaire. - |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Neurology, Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean MFI-20 score for case positive patients | Describes validity of the case definition with regards to the MFI-20 questionnaire | at inclusion in the trial | |
Primary | Mean FSS-7 score for case positive patients | Describes validity of the case definition with regards to the FSS-7 questionnaire | At inclusion in the trial | |
Secondary | inter rater variability of the case definition | Reinterview by a second interviewer | within a week | |
Secondary | Optimal cut off score for case positiveness on MFI-20 and FSS | decide the optimal cut-off score on the two questionnaires to define case positiveness | at inclusion in the trial (which is the time the values used are measured) |
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