Polish Version Fatigue Severity Scale

NCT06668649 | Recruiting

• 1 other identifier: JagiellonianU74
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis; Amyotrophic Lateral Sclerosis; Stroke, Ischemic

Keywords

Fatigue; Multiple Sclerosis; stroke; quality of life

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

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

Diagnostic Test: Testing with Questionnaires

Control

Both sexes, aged 18 or older. The group will include 100 healthy controls.

Diagnostic Test: Testing with Questionnaires

Interventions

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.

Control; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Presence of cognitive deficits or behavioral disorder, which could disturb participation in the study.

Sponsors & Collaborators

• Jakub Antczak: lead
• Institute of Psychiatry and Neurology, Warsaw: collaborator

Study Sites (2)

Jagiellonian University Medical College, Department of Neurology

Krakow, Lesser Poland Voivodeship, 31503, Poland

RECRUITING

Institute of Psychiatry and Neurology

Warsaw, 02957, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 8263569 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Amyotrophic Lateral Sclerosis; Ischemic Stroke; Fatigue; Stroke

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jakub M Antczak, MD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 31, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the study is completed for the period of ten years.
• Access Criteria: Researchers affiliated in institutions listed on clinicaltrials.gov.

Locations

PL (2)