How to Identify Fatigue in Stroke Patients

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

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

Study Overview

• Status: Completed
• Conditions: Stroke; Post Stroke Fatigue
• Intervention / Treatment: Other: questionnaire

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Department of Neurology, Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

stroke patients with a new stroke within 120 days

Description

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. -

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
inter rater variability of the case definition	Reinterview by a second interviewer	within a week
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)

Collaborators and Investigators

• Sponsor: Herlev Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): March 1, 2015

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (ESTIMATE): January 27, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Fatigue
• Other Study ID Numbers: ID 3-3013-583/1/

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO