Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 4:38 AM
Study NCT ID:
NCT07444151
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Stroke Fatigue Perception Study (ReFast)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-16', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fatigue Severity Scale (FSS) Total Score', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': 'Fatigue severity will be assessed using the Fatigue Severity Scale (FSS), a validated 9-item questionnaire measuring subjective fatigue and its functional impact.\n\nEach 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.\n\nHigher scores indicate greater fatigue severity.'}, {'measure': 'Presence of Self-Reported Post-Stroke Fatigue', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': 'Presence of post-stroke fatigue will be assessed using a study-specific Post-Stroke Fatigue Questionnaire developed for this cross-sectional study.\n\nParticipants respond "Yes" or "No" to a binary item assessing whether they have experienced unusual fatigue since their stroke.\n\nThis 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.'}, {'measure': 'Self-Reported Fatigue Intensity', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': 'Fatigue intensity will be assessed using the study-specific Post-Stroke Fatigue Questionnaire.\n\nThe 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).\n\nThe score ranges from 1 to 5. Higher scores indicate greater perceived fatigue intensity.'}, {'measure': 'Self-Reported Functional Impact of Fatigue on Daily Activities', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': '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.\n\nEach item is rated on a 5-point Likert scale ranging from 1 (no impact) to 5 (very high impact).\n\nThe Functional Impact Score is calculated as the mean of these items and ranges from 1 to 5.\n\nHigher scores indicate greater functional limitation related to fatigue.'}, {'measure': 'Self-Reported Frequency of Post-Stroke Fatigue', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': '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).\n\nThis is an ordinal categorical variable. Higher frequency categories reflect more frequent fatigue episodes.'}, {'measure': 'Self-Reported Quality of Life Related to Fatigue', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': 'Quality of life related to fatigue will be assessed using multiple Likert-scale items from the study-specific questionnaire.\n\nEach item is rated from 1 (very poor quality of life) to 5 (very good quality of life).\n\nThe Quality of Life Score is calculated as the mean of these items, ranging from 1 to 5.\n\nHigher scores indicate better perceived quality of life.'}, {'measure': 'Self-Reported Coping Strategies for Managing Fatigue', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': '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.\n\nResults will be summarized descriptively as counts and percentages.'}, {'measure': 'Perceived Social and Professional Support', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': 'Perceived social and professional support will be assessed using multiple Likert-scale items from the study-specific questionnaire.\n\nEach item is rated on a 5-point Likert scale ranging from 1 (no perceived support) to 5 (very strong perceived support).\n\nThe Support Score is calculated as the mean of these items, ranging from 1 to 5.\n\nHigher scores indicate greater perceived support.'}], 'secondaryOutcomes': [{'measure': 'Qualitative Description of Subjective Fatigue Experience', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': 'Open-ended responses describing the subjective experience of fatigue, including emotional, cognitive, and functional aspects, will be collected.\n\nResponses will undergo inductive thematic analysis.'}, {'measure': 'Sociodemographic and Clinical Contextual Variables', 'timeFrame': 'Assessed once at enrollment (single study visit, Day 0)', 'description': 'Sociodemographic and clinical characteristics including age, sex, time since stroke, employment status, level of autonomy, and comorbidities will be collected for descriptive and stratification purposes.\n\nThese are descriptive variables.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-Stroke Fatigue', 'Quality of Life', 'Coping Strategies', 'Questionnaire Study', 'Neurological Rehabilitation', 'Stroke'], 'conditions': ['Post-stroke Fatigue']}, 'descriptionModule': {'briefSummary': '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.\n\nThis study aims to answer these questions:\n\nHow do participants describe their fatigue?\n\nHow strong and how often does it occur?\n\nHow does it affect daily life and quality of life?\n\nWhat strategies do participants use to manage it?\n\nAbout 20 to 30 adults living in French-speaking Switzerland who have had a stroke will take part.\n\nParticipants will:\n\nComplete one anonymous questionnaire online or on paper.\n\nAnswer questions about their fatigue and daily life.\n\nShare their experience in their own words.\n\nThe questionnaire takes about 15 to 20 minutes. There are no medical tests, treatments, or follow-up visits.\n\nParticipation is voluntary. Participants may stop at any time. No names or identifying information are collected.\n\nThe results may help health professionals better understand post-stroke fatigue and improve rehabilitation care.', 'detailedDescription': "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.\n\nThe 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.\n\nData 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.\n\nPrimary 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.\n\nThe 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.\n\nBy 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adults aged 18 years or older living in French-speaking Switzerland who have experienced an ischemic or hemorrhagic stroke and report persistent fatigue in the chronic phase. Participants live in the community and are able to read and understand written French. The study focuses on individuals who self-identify fatigue as a consequence of stroke and who are able to independently complete an anonymous questionnaire about their experience.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Living in French-speaking Switzerland\n* Confirmed history of ischemic or hemorrhagic stroke\n* Self-reported fatigue attributed to stroke\n* Living in the community (not institutionalized)\n* Able to read and understand written French\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Transient ischemic attack (TIA) without confirmed stroke\n* History of two or more strokes\n* Currently institutionalized (e.g., nursing home, long-term hospital care, rehabilitation center)\n* Fatigue primarily caused by another chronic medical condition (e.g., cancer, primary depression, multiple sclerosis)\n* Severe cognitive or communication impairment preventing independent completion of the questionnaire\n* Unable to understand written French'}, 'identificationModule': {'nctId': 'NCT07444151', 'acronym': 'ReFast', 'briefTitle': 'Post-Stroke Fatigue Perception Study (ReFast)', 'organization': {'class': 'OTHER', 'fullName': 'School of Health Sciences Geneva'}, 'officialTitle': 'Exploration of Subjective Post-Stroke Fatigue: A Mixed-Methods Questionnaire Study (ReFast - Recovery and Fatigue Study)', 'orgStudyIdInfo': {'id': '2025-02382'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults With Chronic Stroke and Post-Stroke Fatigue', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1227', 'city': 'Carouge', 'state': 'Canton of Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Pierre Nicolo, PhD', 'role': 'CONTACT', 'email': 'pierre.nicolo@hesge.ch', 'phone': '+41 22 558 64 51'}], 'facility': 'Haute école de santé de Genève (HEdS - HES-SO)', 'geoPoint': {'lat': 46.18096, 'lon': 6.13921}}], 'centralContacts': [{'name': 'Pierre Nicolo, PhD', 'role': 'CONTACT', 'email': 'pierre.nicolo@hesge.ch', 'phone': '+41079263543', 'phoneExt': '+41 22 558 64'}], 'overallOfficials': [{'name': 'Pierre Nicolo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HEdS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared because all data are collected anonymously and without any direct or indirect identifiers. The dataset is limited to a small exploratory sample collected within the framework of an academic Bachelor project. In accordance with the study protocol and institutional policies, the data are intended solely for the objectives described in the approved research project. Any future reuse of the data would require a new ethics application and approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'School of Health Sciences Geneva', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pierre Nicolo, PhD', 'investigatorAffiliation': 'School of Health Sciences Geneva'}}}}