Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
Study NCT ID:
NCT07211516
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relationship Between Cognition, Workforce Participation and Well-Being in Individuals With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-09-30', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Work participation', 'timeFrame': 'Baseline', 'description': 'Percentage of full-time work. 100 % full-time work and 0% is not working at all.'}, {'measure': 'Hospital anxiety and depression scale (HADS)', 'timeFrame': 'Baseline', 'description': 'Self-assessment of anxiety and depression. Consists of two scales measuring the probability of having anxiety and depression respectively. Min score 0, max 21 for each scale. Higher scores indicate higher probability of anxiety/depression.'}, {'measure': 'WHO-5 Well-Being Index', 'timeFrame': 'Baseline', 'description': 'Overall rating of well-being. The WHO-5 score range is a raw score of 0-25, which is then multiplied by 4 to get a percentage score of 0-100. Higher score indicates higher well-being.'}, {'measure': 'Brief index of job satisfaction (BIAJS)', 'timeFrame': 'Baseline', 'description': 'The Brief Index of Affective Job Satisfaction (BIAJS) has a score range of 1 to 5 for each of its four items, based on a 5-point Likert scale where 1 is "strongly disagree" and 5 is "strongly agree". The total BIAJS score is the sum of these four items, resulting in a possible range from 4 to 20, with higher scores indicating greater affective job satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Work-life balance', 'timeFrame': 'Baseline', 'description': 'Questions from the subscale "Quantitative demands" of the Copenhagen Psychosocial Questionnaire (COPSOQ-III) related to the demands of work. The COPSOQ-III uses Likert-like scales, and its items are coded with values of 0, 25, 50, 75, and 100 to achieve a 0-100 scale. Higher scores indicate more demands.'}, {'measure': 'Can-Work-S', 'timeFrame': 'Baseline', 'description': 'Three questions from a questionnaire developed to measure work-life balance after cancer. Each item ranges from 1 to 5 with higher scores indicating worse work-life balance.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis (MS) is a chronic neurodegenerative disease and a leading cause of reduced workforce participation due to neurological illness in Western countries. Over the past 30 years, new treatments have reduced symptom burden, allowing patients to stay in the workforce longer. However, fatigue and cognitive impairments remain major barriers to work capacity. This project aims to examine factors important for work ability and well-being in persons with MS and cognitive impairments. The specific research questions are:\n\n1. How do job type and opportunities for workplace adaptations influence work ability and well-being in individuals with MS and cognitive impairments?\n2. What are the associations between cognitive function in MS and work ability as well as well-being? The investigators plan to collect data on patients with MS who have undergone a neuropsychological assessment at the neurology clinic in Region Gävleborg over a five year period. Approximately 100 patients are eligible for participation. Data will be collected through surveys and by extracting information from medical records. The surveys include questions related to well-being and work ability. Data from medical records contain data from the neuropsychological assessment, other rehabilitation interventions as well as data related to treatment and progress of MS.\n\nThe findings from the study aim to enhance work-oriented rehabilitation and provide a deeper understanding of how to support individuals with MS in maintaining employment and overall well-being'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of working age with MS in Region Gävleborg who have performed a neuropsychological assessment during the 5 years prior to study start and who are not suffering from other diagnosis which impact their work ability to a large extent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMultiple sclerosis Age between 18-65 Performed a neuropsychological assessment at the Neurology department at Gävle Hospital during the last 5 years (counting from study start) -\n\nExclusion Criteria:\n\nOther diagnosis hindering work participation more than MS\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07211516', 'briefTitle': 'Relationship Between Cognition, Workforce Participation and Well-Being in Individuals With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Region Gävleborg'}, 'officialTitle': 'Improving Workforce Participation and Well-Being in Individuals With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'MSCogWork2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with MS and of working age (18-65) who have been referred to neuropsychological evaluation.', 'description': 'Time of neuropsychological assessment from 5 years before until study start.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gävle', 'country': 'Sweden', 'contacts': [{'name': 'Natascha Ekdahl', 'role': 'CONTACT', 'email': 'natascha.ekdahl@regiongavleborg.se', 'phone': '+4626278023'}], 'facility': 'Gävle hospital', 'geoPoint': {'lat': 60.67452, 'lon': 17.14174}}], 'centralContacts': [{'name': 'Natascha Ekdahl', 'role': 'CONTACT', 'email': 'natascha.ekdahl@regiongavleborg.se', 'phone': '+4626278023'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To comply with the conditions set by the ethical review board, individual participant data (IPD) cannot be shared with other researchers. However, aggregated data are available upon reasonable reques'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Gävleborg', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Gavle', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}