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How to Identify Fatigue in Stroke Patients

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ClinicalTrials.gov Identifier: NCT03034590
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Karsten Overgaard, Herlev Hospital

Brief Summary:
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

Condition or disease Intervention/treatment
Post Stroke Fatigue Stroke Other: questionnaire

Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How to Identify Fatigue in Stroke Patients: Validity of the Post-stroke Fatigue Case Definition
Study Start Date : August 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue




Primary Outcome Measures :
  1. Mean MFI-20 score for case positive patients [ Time Frame: at inclusion in the trial ]
    Describes validity of the case definition with regards to the MFI-20 questionnaire

  2. Mean FSS-7 score for case positive patients [ Time Frame: At inclusion in the trial ]
    Describes validity of the case definition with regards to the FSS-7 questionnaire


Secondary Outcome Measures :
  1. inter rater variability of the case definition [ Time Frame: within a week ]
    Reinterview by a second interviewer

  2. Optimal cut off score for case positiveness on MFI-20 and FSS [ Time Frame: at inclusion in the trial (which is the time the values used are measured) ]
    decide the optimal cut-off score on the two questionnaires to define case positiveness



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
stroke patients with a new stroke within 120 days
Criteria

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. -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034590


Locations
Denmark
Department of Neurology, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
Investigators
Principal Investigator: Karsten Overgaard, MD Department of Neurology, Herlev Hospital

Responsible Party: Karsten Overgaard, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT03034590     History of Changes
Other Study ID Numbers: ID 3-3013-583/1/
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Stroke
Fatigue
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms