Validation of Polish Language Version of Fatigue Severity Scale
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Jakub Antczak
- Enrollment
- 310
- Locations
- 2
- Primary Endpoint
- Internal Consistency
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
Fatigue is one of main symptoms in multiple sclerosis, amyotrophic lateral sclerosis, post-polio syndrome, stroke, parkinsonism as well as in the chronic fatigue syndrome. It has profound effect on quality of life and professional and social functioning and in multiple sclerosis it is described as the worst symptoms by the 50% of patients. It is defined as the difficulty in initiating and maintaining a sustained mental or physical activity. Not infrequent it is misdiagnosed as sleepiness or other symptom. Fatigue severity scale (FSS) is a time efficient and easy to apply instrument to assess the impact of fatigue on patient's life. It has been translated and validated in Turkish, Russian, Hindi, Portuguese, and many other languages. FSS is a short, nine-item self-report questionnaire. Each item is a Likert scale, scored from one to seven, where seven refers to the most severely expressed aspect of fatigue. The aim of this study is to validate the Polish-language version of the Fatigue Severity Scale (pFSS). This version has been created according to widely accepted, respective standards, including translation by two independent native Polish-language speakers with acquired knowledge of English and backward translation by two independent native English-language speakers with acquired knowledge of Polish as well as with the pretesting on ten patients.
Investigators
Jakub Antczak
Principal Investigator
Jagiellonian University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Presence of cognitive deficits or behavioral disorder, which could disturb participation in the study.
Outcomes
Primary Outcomes
Internal Consistency
Time Frame: Through study completion, an average of 1 year
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.
Validity
Time Frame: Through study completion, an average of 1 year
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.
Reliability
Time Frame: Through study completion, an average of 1 year
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.
Secondary Outcomes
- Impact of fatigue on quality of life - index(Through study completion, an average of 1 year)
- Impact of fatigue on quality of life - visual analogue scale(Through study completion, an average of 1 year)
- Impact of fatigue on depression(Through study completion, an average of 1 year)
- Difference in fatigue level between patients and controls(Through study completion, an average of 1 year)