How to Identify Fatigue in Stroke Patients

Stroke Clinical Trial

Official title:

How to Identify Fatigue in Stroke Patients: Validity of the Post-stroke Fatigue Case Definition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034590
• Other study ID #: ID 3-3013-583/1/
• Status: Completed
• Phase: N/A
• First received: October 12, 2016
• Last updated: January 25, 2017
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: January 2017
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• 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. -

Related Conditions & MeSH terms

• Fatigue
• Post Stroke Fatigue
• Stroke

Intervention

Other:
• questionnaire

Locations

Country	Name	City	State
Denmark	Department of Neurology, Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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)