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临床试验/NCT07444151
NCT07444151招募中不适用

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

School of Health Sciences Geneva1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Fatigue Severity Scale (FSS) Total Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Adults With Chronic Stroke and Post-Stroke Fatigue

Adults aged 18 years or older living in French-speaking Switzerland who have experienced a stroke and report persistent fatigue in the chronic phase (six months or more after stroke). Participants live in the community and complete one anonymous questionnaire about their experience of fatigue, its impact on daily life, and coping strategies. No medical intervention or follow-up is involved.

结局指标

主要结局

Fatigue Severity Scale (FSS) Total Score

时间窗: Assessed once at enrollment (single study visit, Day 0)

Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a validated 9-item questionnaire measuring subjective fatigue and its functional impact. Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the mean of the 9 items and ranges from 1 to 7. Higher scores indicate greater fatigue severity.

Presence of Self-Reported Post-Stroke Fatigue

时间窗: Assessed once at enrollment (single study visit, Day 0)

Presence of post-stroke fatigue will be assessed using a study-specific Post-Stroke Fatigue Questionnaire developed for this cross-sectional study. Participants respond "Yes" or "No" to a binary item assessing whether they have experienced unusual fatigue since their stroke. This is a categorical variable (Yes/No). The proportion of participants reporting "Yes" will be calculated. Higher frequency of "Yes" responses indicates greater prevalence of self-reported post-stroke fatigue.

Self-Reported Fatigue Intensity

时间窗: Assessed once at enrollment (single study visit, Day 0)

Fatigue intensity will be assessed using the study-specific Post-Stroke Fatigue Questionnaire. The Fatigue Intensity Score is calculated as the mean of multiple items rated on a 5-point Likert scale ranging from 1 (low fatigue) to 5 (very high fatigue). The score ranges from 1 to 5. Higher scores indicate greater perceived fatigue intensity.

Self-Reported Functional Impact of Fatigue on Daily Activities

时间窗: Assessed once at enrollment (single study visit, Day 0)

Functional impact of fatigue on daily activities (e.g., household tasks, work, leisure, rehabilitation) will be assessed using multiple structured items from the study-specific questionnaire. Each item is rated on a 5-point Likert scale ranging from 1 (no impact) to 5 (very high impact). The Functional Impact Score is calculated as the mean of these items and ranges from 1 to 5. Higher scores indicate greater functional limitation related to fatigue.

Self-Reported Frequency of Post-Stroke Fatigue

时间窗: Assessed once at enrollment (single study visit, Day 0)

Frequency of fatigue will be assessed using a structured categorical item in the study-specific questionnaire with predefined response options (e.g., daily, several times per week, occasionally, rarely). This is an ordinal categorical variable. Higher frequency categories reflect more frequent fatigue episodes.

Self-Reported Quality of Life Related to Fatigue

时间窗: Assessed once at enrollment (single study visit, Day 0)

Quality of life related to fatigue will be assessed using multiple Likert-scale items from the study-specific questionnaire. Each item is rated from 1 (very poor quality of life) to 5 (very good quality of life). The Quality of Life Score is calculated as the mean of these items, ranging from 1 to 5. Higher scores indicate better perceived quality of life.

Self-Reported Coping Strategies for Managing Fatigue

时间窗: Assessed once at enrollment (single study visit, Day 0)

Coping strategies used to manage fatigue (e.g., rest breaks, activity planning, physical activity) will be assessed using predefined multiple-choice items and optional open-ended responses in the study-specific questionnaire. Results will be summarized descriptively as counts and percentages.

Perceived Social and Professional Support

时间窗: Assessed once at enrollment (single study visit, Day 0)

Perceived social and professional support will be assessed using multiple Likert-scale items from the study-specific questionnaire. Each item is rated on a 5-point Likert scale ranging from 1 (no perceived support) to 5 (very strong perceived support). The Support Score is calculated as the mean of these items, ranging from 1 to 5. Higher scores indicate greater perceived support.

次要结局

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

研究者

发起方
School of Health Sciences Geneva
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pierre Nicolo, PhD

Professor

School of Health Sciences Geneva

研究点 (1)

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