Post-Stroke Fatigue Perception Study (ReFast)

Официальное название

Exploration of Subjective Post-Stroke Fatigue: A Mixed-Methods Questionnaire Study (ReFast - Recovery and Fatigue Study)

Обзор

The goal of this observational study is to better understand fatigue after stroke. Many people feel ongoing tiredness months or years after a stroke. This fatigue may affect daily activities, work, and social life. It does not always improve with rest. This study aims to answer these questions: How do participants describe their fatigue? How strong and how often does it occur? How does it affect daily life and quality of life? What strategies do participants use to manage it? About 20 to 30 adults living in French-speaking Switzerland who have had a stroke will take part. Participants will: Complete one anonymous questionnaire online or on paper. Answer questions about their fatigue and daily life. Share their experience in their own words. The questionnaire takes about 15 to 20 minutes. There are no medical tests, treatments, or follow-up visits. Participation is voluntary. Participants may stop at any time. No names or identifying information are collected. The results may help health professionals better understand post-stroke fatigue and improve rehabilitation care.

Подробное описание

Post-stroke fatigue is a common and long-lasting symptom experienced by many people after a stroke. It is described as persistent physical, cognitive, or emotional exhaustion that is not proportional to effort and does not consistently improve with rest. Although fatigue can strongly affect participation, autonomy, and quality of life, it remains insufficiently understood and often under-recognized in rehabilitation practice.

The ReFast study (Recovery and Fatigue Study) is a non-interventional, cross-sectional observational study conducted in French-speaking Switzerland. The aim is to explore the subjective experience of post-stroke fatigue in adults living at home in the chronic phase after stroke. The study focuses on understanding how participants perceive their fatigue, how it affects daily life, and which coping strategies they use.

Data will be collected through a single anonymous questionnaire that combines structured questions (including rating scales and multiple-choice items) with open-ended questions. This mixed-methods approach allows both quantitative description and qualitative exploration of participants' experiences.

Primary outcomes relate to the presence, intensity, frequency, and functional impact of fatigue. Secondary outcomes include perceived quality of life, coping strategies, perceived social or professional support, and contextual factors such as age and time since stroke. Open-ended responses will be analyzed using inductive thematic analysis to identify recurring themes and patterns.

The study does not involve any medical intervention, clinical examination, or follow-up visit. Participation consists of completing one questionnaire session. All data are collected anonymously, and no identifying information is recorded. The overall risk is minimal and limited to possible mild emotional discomfort when reflecting on personal experiences.

By integrating quantitative and qualitative perspectives, this study seeks to generate clinically relevant insights into post-stroke fatigue. The findings may support the development of more patient-centered rehabilitation approaches and inform future research in neurological rehabilitation.

Первичные конечные точки

• Fatigue Severity Scale (FSS) Total Score [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]
• Presence of Self-Reported Post-Stroke Fatigue [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]
• Self-Reported Fatigue Intensity [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]
• Self-Reported Functional Impact of Fatigue on Daily Activities [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]
• Self-Reported Frequency of Post-Stroke Fatigue [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]
• Self-Reported Quality of Life Related to Fatigue [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]
• Self-Reported Coping Strategies for Managing Fatigue [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]
• Perceived Social and Professional Support [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]

Вторичные конечные точки (2)

• Qualitative Description of Subjective Fatigue Experience [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]
• Sociodemographic and Clinical Contextual Variables [Срок оценки: Assessed once at enrollment (single study visit, Day 0)]

Критерии участия

Критерии включения

• Age 18 years or older
• Living in French-speaking Switzerland
• Confirmed history of ischemic or hemorrhagic stroke
• Self-reported fatigue attributed to stroke
• Living in the community (not institutionalized)
• Able to read and understand written French
• Able to provide informed consent

Критерии исключения

• Transient ischemic attack (TIA) without confirmed stroke
• History of two or more strokes
• Currently institutionalized (e.g., nursing home, long-term hospital care, rehabilitation center)
• Fatigue primarily caused by another chronic medical condition (e.g., cancer, primary depression, multiple sclerosis)
• Severe cognitive or communication impairment preventing independent completion of the questionnaire
• Unable to understand written French

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• Haute école de santé de Genève (HEdS - HES-SO) — Carouge

Идентификаторы

NCT: NCT07444151 · 2025-02382

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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