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| Name | Class |
|---|---|
| Institute of Psychiatry and Neurology, Warsaw | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Both sexes, aged 18 or older. The group will include 80 patients with multiple sclerosis, 80 patients with amyotrophic lateral sclerosis and 50 survivors of ischemic stroke |
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| Control | Both sexes, aged 18 or older. The group will include 100 healthy controls. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testing with Questionnaires | Diagnostic Test | Testing 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
| 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. | Through study completion, an average of 1 year |
| 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jakub M Antczak, MD | Contact | +48 12 400 25 50 | jakub.antczak@uj.edu.pl | |
| Gabriela G Rusin, MD | Contact | +48 12 400 25 50 | gabriela.rusin@alumni.uj.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Jakub M Antczak, MD | Jagiellonian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jagiellonian University Medical College, Department of Neurology | Recruiting | Krakow | Lesser Poland Voivodeship | 31503 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8263569 | Background | Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n. |
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After the study is completed, the scans of collected questionnaires will be available upon request sent to the e-mail: jakub.antczak@uj.edu.pl
After the study is completed for the period of ten years.
Researchers affiliated in institutions listed on clinicaltrials.gov.
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D000690 | Amyotrophic Lateral Sclerosis |
| D000083242 | Ischemic Stroke |
| D005221 | Fatigue |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Through study completion, an average of 1 year |
| 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. | Through study completion, an average of 1 year |
| 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. | Through study completion, an average of 1 year |
| 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. | Through study completion, an average of 1 year |
| Institute of Psychiatry and Neurology | Recruiting | Warsaw | 02957 | Poland |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |