Polish Version Fatigue Severity Scale

November 7, 2024 updated by: Jakub Antczak

Validation of Polish Language Version of Fatigue Severity Scale

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

310

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
      • Warsaw, Poland, 02957
        • Recruiting
        • Institute of Psychiatry and Neurology
        • Contact:
        • Contact:
    • Lesser Poland
      • Kraków, Lesser Poland, Poland, 31503
        • Recruiting
        • Jagiellonian University Medical College, Department of Neurology
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Magdalena Spaczyńska-Boczar, MD
        • Sub-Investigator:
          • Marcin Wnuk, MD
        • Sub-Investigator:
          • Gabriela G Rusin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
Both sexes, aged 18 or older. The group will include 100 healthy controls.
Diagnostic test: Testing with Questionnaires
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of fatigue on quality of life - index
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
Impact of fatigue on quality of life - visual analogue scale
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jakub Antczak

Collaborators

Institute of Psychiatry and Neurology, Warsaw

Investigators

  • Principal Investigator: Jakub M Antczak, MD, Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JagiellonianU74

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

After the study is completed for the period of ten years.

IPD Sharing Access Criteria

Researchers affiliated in institutions listed on clinicaltrials.gov.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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