Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-01-15 @ 2:56 AM
Study NCT ID:
NCT06594120
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IMBA - Profile comparison', 'timeFrame': '3 or 4 weeks of inpatient rehabilitation', 'description': 'IMBA is a profile comparison method for prevention and rehabilitation. Job requirements and human capabilities are described by standardised, defined characteristics and compared directly with each other. The respective profile sheets consist, among other things, of 70 function-, activity- and context-related main characteristics in which the extent of excessive demands for each characteristic is documented on a scale of 0 - 6 (Min. = 0, Max = 420). Lower values indicate less excessive demands.'}, {'measure': 'Employment history', 'timeFrame': '6 and 12 months after finishing rehabilitation', 'description': 'The existence of gainful employment subject to social insurance contributions in a specific period allows conclusions to be drawn about the employment history of the rehabilitants.'}], 'secondaryOutcomes': [{'measure': 'Work ability index (WAI)', 'timeFrame': '3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation', 'description': 'The Work Ability Index (WAI) is an instrument for assessing work ability. (Min. = 7, Max = 49). Lower values indicate less subjective work ability.'}, {'measure': 'Patient Health Questionnaire-4 (PHQ-4)', 'timeFrame': '3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation', 'description': 'The Patient Health Questionnaire-4 (PHQ-4) operationalizes core criteria for anxiety and depression on a 4 point likert scale (Min. = 0, Max = 4). Lower values indicate less impairments.'}, {'measure': 'European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)', 'timeFrame': '3 or 4 weeks of inpatient rehabilitation + 6 and 12 months after finishing rehabilitation', 'description': "The EQ-5D-5L is a general instrument for measuring patient-reported outcomes (PROs), which can be used to assess the quality of life of patients on different dimensions (mobility, self-care, usual activities, pain/discomfort) on a 5-level scale (Min. = 0, Max. = 5). Lower values indicate less impairments in the respective dimensions.\n\nMoreover, the EQ-5D-5L assesses the patient's self-rated health on a 100 point visual analog scale (Min. = 0, Max. = 100). Lower values indicate less positive ratings of health."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Diseases or Conditions']}, 'descriptionModule': {'briefSummary': 'The objective of this observational study is to gain insight into a new approach to rehabilitation in Austria, with a particular focus on work-specific exercises that are dependent on the specific work-related needs of the patients. Two groups are being observed: one was referred to a three-week work-specific rehabilitation programme immediately upon arrival at the rehabilitation centre, while the other group underwent a three-week medical-focused rehabilitation programme before starting a four-week work-specific rehabilitation programme.\n\nResearchers will monitor for indications of improvement following completion of the rehabilitation program. As the two forms of rehabilitation are not directly comparable, they will be observed and analysed as two distinct entities.\n\nAs part of their regular inpatient rehabilitation, participants will complete questionnaires at designated intervals (beginning and end of stay), with follow-up assessments scheduled at six and 12 months post-rehabilitation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with specific work-related rehabilitation needs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study participants are regular patients in the rehabilitation centre Bad Hofgastein\n* Presence of a disease in the area of the musculoskeletal system\n* Sufficient motivation to maintain professional participation\n* Declaration of consent\n\nExclusion Criteria:\n\n* No completion of all work-specific rehabilitation modules\n* Acute or decompensated disease states with severe functional limitations (i.e. not able to continue with the rehabilitation programme)'}, 'identificationModule': {'nctId': 'NCT06594120', 'briefTitle': 'Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET', 'organization': {'class': 'OTHER', 'fullName': 'Pensionsversicherungsanstalt'}, 'officialTitle': 'Veränderungen Der Arbeitsfähigkeit Und Erwerbstätigkeit Infolge Des Medizinisch Berufsorientierten Rehabilitationsverfahrens PV RehaJET [Changes in Workability and Employment Following the Work-related Medical Rehabilitation PV RehaJET]', 'orgStudyIdInfo': {'id': '0031 Studie PVRehaJET als EV'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3-week work-specific rehabilitation', 'description': 'This group is referred to the work-specific rehabilitation programme immediately upon arrival at the rehabilitation centre.', 'interventionNames': ['Behavioral: Multimodal rehabilitation with additional work specific training']}, {'label': '4-week work-specific rehabilitation', 'description': 'This group first underwent a three-week medical-focused rehabilitation programme prior to commencing the work-specific rehabilitation programme.', 'interventionNames': ['Behavioral: Multimodal rehabilitation with additional work specific training']}], 'interventions': [{'name': 'Multimodal rehabilitation with additional work specific training', 'type': 'BEHAVIORAL', 'description': 'The rehabilitation is based on the biopsychosocial ICF model of the WHO. Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to the needs of the patients.', 'armGroupLabels': ['3-week work-specific rehabilitation', '4-week work-specific rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5630', 'city': 'Bad Hofgastein', 'state': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Martin Pelitz, Dr.', 'role': 'CONTACT', 'email': 'martin.pelitz@pv.at', 'phone': '+4364326685'}], 'facility': 'Rehabilitationszentrum Bad Hofgastein', 'geoPoint': {'lat': 47.17274, 'lon': 13.09871}}], 'centralContacts': [{'name': 'Stefan Gschwenter, MA', 'role': 'CONTACT', 'email': 'stefan.gschwenter@pv.at', 'phone': '+43 50303 - 26722'}], 'overallOfficials': [{'name': 'Doreen Stöhr, Mag.', 'role': 'STUDY_CHAIR', 'affiliation': 'Pensionsversicherungsanstalt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pensionsversicherungsanstalt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}