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Идёт набор NCT06668649

Polish Version Fatigue Severity Scale

— Наблюдательное Multiple Sclerosis Amyotrophic Lateral Sclerosis Stroke, Ischemic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Testing with Questionnaires.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Stroke, Ischemic. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Validation of Polish Language Version of Fatigue Severity Scale

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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.

Первичные конечные точки

  • Internal Consistency [Срок оценки: Through study completion, an average of 1 year]
  • Validity [Срок оценки: Through study completion, an average of 1 year]
  • Reliability [Срок оценки: Through study completion, an average of 1 year]
Вторичные конечные точки (4)
  • Impact of fatigue on quality of life - index [Срок оценки: Through study completion, an average of 1 year]
  • Impact of fatigue on quality of life - visual analogue scale [Срок оценки: Through study completion, an average of 1 year]
  • Impact of fatigue on depression [Срок оценки: Through study completion, an average of 1 year]
  • Difference in fatigue level between patients and controls [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Польша · 2 центра
  • Jagiellonian University Medical College, Department of Neurology — Krakow
  • Institute of Psychiatry and Neurology — Warsaw

Публикации

  • 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

Идентификаторы

NCT: NCT06668649 · JagiellonianU74

Первоисточники (государственные реестры)

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