Polish Version Fatigue Severity Scale
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJakub Antczak
About this trial
Fatigue is one of main symptoms in multiple sclerosis, amyotrophic lateral sclerosis and other diseases with profound effect on quality of life and professional and social functioning. Not infrequent it is misdiagnosed as sleepiness or other symptom. Fatigue severity scale is a time efficient and easy to apply instrument to assess the impact of fatigue on patient's life. The aim of this study is to validate the Polish-language version of the Fatigue Severity Scale.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosis of definite multiple sclerosis or definite, laboratory-supported multiple sclerosis, or definite amyotrophic lateral sclerosis, or probable amyotrophic lateral sclerosis or probable, laboratory supported amyotrophic lateral sclerosis or ischemic stroke or - for healthy controls - lack of diseases, pharmacotherapy or habits, which could induce abnormal tiredness
Disqualifiers
Presence of cognitive deficits or behavioral disorder, which could disturb participation in the study.
Trial population
Participants will be recruited from the neurologic ambulatories and neurologic clinics of Jagiellonian University Medical College in Cracow and of Institute of Psychiatry and Neurology in Warsaw. Healthy controls will be recruited from personel of those facitlites as well as from the relatives of members of research team.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Testing with Questionnaires
Diagnostic testTesting with following Questionnaires: pFSS, Polish-language version of Modified Fatigue Impact Scale, Visual Analogue Scale of Fatigue, EQ-5D-5L (EuroQol-5 dimension) questionnaire, Beck Depression Inventory II. In randomly selected 30 patients and 20 controls questionnaires will be administered twice with two weeks interval to assess the test-retest reliability.
Treatment groups
310 Participants
are divided into 2 treatment groupsGroup A: Patients1 intervention
Group B: Control1 intervention
Trial outcomes
Primary outcomes
1
Internal Consistency
Consistency between particular items of Polish language version of the Fatigue Severity Scale will be evaluated using Cronbach alfa test. The score of the Polish language version of the Fatigue Severity Scale ranges between 9 and 63 with higher scores meaning a worse outcome.
Time frame
Through study completion, an average of 1 year2
Validity
Validity will be tested by calculating the correlation of Polish language version of the Fatigue Severity Scale score with scores of Polish-language version of Modified Fatigue Impact Scale. The score of the Polish language version of the Fatigue Severity Scale ranges between 9 and 63 with higher scores meaning a worse outcome. The score of the Modified Fatigue Impact Scale ranges between 0 and 84 with higher scores meaning a worse outcome.
Time frame
Through study completion, an average of 1 year3
Reliability
Reliability will be tested by calculating the correlation between Polish language version of the Fatigue Severity Scale scores from the 1st and 2nd administration in the randomly selected subgroup of patients and controls. The score of the Polish language version of the Fatigue Severity Scale ranges between 9 and 63 with higher scores meaning a worse outcome.
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Impact of fatigue on quality of life - index
Correlation between Polish language version of the Fatigue Severity Scale score and the index score of EQ-5D-5L (EuroQol-5 dimension) questionnaire. The score of the Polish language version of the Fatigue Severity Scale ranges between 9 and 63 with higher scores meaning a worse outcome. The index score of EQ-5D-5L (EuroQol-5 dimension) questionnaire ranges between -0.59 to 1 with higher scores indicating better outcome.
Time frame
Through study completion, an average of 1 year2
Impact of fatigue on quality of life - visual analogue scale
Correlation between Polish language version of the Fatigue Severity Scale score and the visual analogue scale score of EQ-5D-5L (EuroQol-5 dimension) questionnaire. The score of the Polish language version of the Fatigue Severity Scale ranges between 9 and 63 with higher scores meaning a worse outcome. The visual analogue scale score of EQ-5D-5L (EuroQol-5 dimension) questionnaire ranges between 0 to 100 with higher scores indicating better outcome.
Time frame
Through study completion, an average of 1 year3
Impact of fatigue on depression
Correlation between Polish language version of the Fatigue Severity Scale score and score of Beck Depression Inventory II. The score of the Polish language version of the Fatigue Severity Scale ranges between 9 and 63 with higher scores meaning a worse outcome. The score of the Beck Depression Inventory II ranges between 0 and 63 with higher scores indicating worse outcome.
Time frame
Through study completion, an average of 1 year4
Difference in fatigue level between patients and controls
Difference in Polish language version of the Fatigue Severity Scale score between patients and controls. The score of the Polish language version of the Fatigue Severity Scale ranges between 9 and 63 with higher scores meaning a worse outcome.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jakub Antczak
Lead sponsor
Jagiellonian University
Sponsor institution
Institute of Psychiatry and Neurology, Warsaw
Collaborator
Source ClinicalTrials.gov