Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT04196634
Status:
UNKNOWN
Last Update Posted:
2023-02-17
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003095', 'term': 'Collagen Diseases'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018570', 'term': 'Risk Assessment'}], 'ancestors': [{'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012308', 'term': 'Risk Management'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-25', 'size': 502812, 'label': 'Study Protocol and Statistical Analysis Plan: Statistical Analysis Plan - Prognostic factors', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-30T11:43', 'hasProtocol': True}, {'date': '2023-02-06', 'size': 495686, 'label': 'Statistical Analysis Plan: Statistical Analysis Plan - Prognostic model', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-14T00:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 560}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-12-11', 'lastUpdatePostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Keele STarT MSK Screening tool', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The STarT MSK consists of 10 items and the scores are summarized to a 0-12 score, with risk groups being categorized as follow: 0-4= low risk; 5-8= medium risk; 9-12= high risk of developing long-term pain or disability.'}, {'measure': 'Örebro Musculoskeletal Pain Screening Questionnaire short form (ÖMPSQ -sf)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'ÖMPSQ-sf contains 10 questions that are summed up to 0 to 100 score, with higher score indicating higher risk developing work disability.'}, {'measure': 'Work conflict', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Single question on work conflict: "Did you experience conflict(s) with your employer before you got sick-listed?" (Yes/No)'}, {'measure': 'Work satisfaction', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Measured with a single question: "If you take into consideration your work routines, management, salary, promotion possibilities and work mates, how satisfied are you with your job?" Measured on a numeric rating scale, 0=Not satisfied at all, 10=Completely satisfied\n\nMeasured with a single question: "Do you want to return to the same work/position or do you wish you had another work/position?" Answered with: Same work/position / Another work/position.'}, {'measure': 'Work ability', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Measured with a single question from the Work Ability Index: "Assume that your work ability at its best has a value of 10 ponts. How many points would you give to your current work ability?" Measured on a numeric rating scale where 0 means that you cannot currently work at all, 10 means that your work ability is at its best right now.'}, {'measure': 'Return to work expectancy', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Measured with a single question: "For how long do you believe you will be sick listed from today?" Answered with: Not at all / Less than 1 month / 1-2 months / 2-4 months / 4-10 months / More than 10 months'}, {'measure': 'Demographic variables', 'timeFrame': 'Baseline', 'description': 'Gender, age, diagnosis'}, {'measure': 'Change in condition', 'timeFrame': '4 weeks', 'description': '7-point global rating of change: "Could you please state the amount of change concerning your musculoskeletal symptoms compared to when you first filled out this questionnaire". Answered with: Much better / Better / Slightly better / Unchanged / Slightly worse / Worse / Much worse'}], 'primaryOutcomes': [{'measure': 'Sickness absence days', 'timeFrame': '12 months', 'description': 'Total number of absence days during 12 months of follow-up adjusted for percentage of work and percentage of sickness absence. Register data from the national health and welfare services'}, {'measure': 'Time to sustainable return to work', 'timeFrame': '12 months', 'description': 'The time until full sustainable return to work, i.e. at least 4 weeks without relapse during 12 months of follow-up. Register data from the national health and welfare services'}, {'measure': 'Probability of return to work', 'timeFrame': '12 months', 'description': 'Probability of working (i.e. not receiving medical benefits) each month during 12 months of follow-up, measured as repeated events. Register data from the national health and welfare services'}, {'measure': 'Proportion who have returned to work', 'timeFrame': '12 months', 'description': 'Proportion of people with sustainable return to work (at least 4 weeks) at 12 months. Register data from the national health and welfare services'}, {'measure': 'Health care costs', 'timeFrame': '12 months', 'description': 'Use of health care will be collected from public registries including Norwegian Patient Registry (NPR), Municipal Patient and User Registry (KPR) and Control and Payment of Health Refunds (KUHR).'}, {'measure': 'Sickness absence costs', 'timeFrame': '12 months', 'description': 'Sickness absence costs will be calculated based on data from the NAV registry'}], 'secondaryOutcomes': [{'measure': 'Musculoskeletal Health Questionnaire (MSK-HQ)', 'timeFrame': 'Baseline and 4 weeks', 'description': '14 questions scored on a 0-4-point scale, summed up to a 0 to 56 points score, with higher score indicating better musculoskeletal health.'}, {'measure': 'EuroQol 5 Dimensions (EQ5D-5L)', 'timeFrame': 'Baseline and 4 weeks', 'description': "The EQ5D-5L covers five domains: mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression, scored on a 5-point scale from 0 (worst imaginable health) to 5 (best imaginable health). Responses can be transformed into an index ranging from -0.59 to 1, where -0.59 represents worst possible state and 1 represents perfect health. The EQ5D Visual Analogue Scale (VAS) is also included, which is a question asking about the respondent's self-rated health on a vertical 0 to 100 visual analog scale, with 100 being best health."}, {'measure': 'Institute of Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Measure and value health-related productivity loss for both paid and unpaid work. The instrument is found to be suitable for measuring absenteeism from paid work and productivity loss related to unpaid labor. Nine questions related to paid work and three questions related to unpaid work.'}, {'measure': 'Sickness absence days', 'timeFrame': '6 months', 'description': 'Total number of absence days during 6 months of follow-up adjusted for percentage of work and percentage of sickness absence. Register data from the national health and welfare services'}, {'measure': 'Time to sustainable return to work', 'timeFrame': '6 months', 'description': 'The time until full sustainable return to work, i.e. at least 4 weeks without relapse during 6 months of follow-up. Register data from the national health and welfare services'}, {'measure': 'Proportion who have returned to work', 'timeFrame': '6 months', 'description': 'Proportion of people with sustainable return to work (at least 4 weeks) at 6 months. Register data from the national health and welfare services'}, {'measure': 'Probability of return to work', 'timeFrame': '6 months', 'description': 'Probability of working (i.e. not receiving medical benefits) each month during 6 months of follow-up, measured as repeated events. Register data from the national health and welfare services'}, {'measure': 'Health care costs', 'timeFrame': '6 months', 'description': 'Use of health care will be collected from public registries including Norwegian Patient Registry (NPR), Municipal Patient and User Registry (KPR) and Control and Payment of Health Refunds (KUHR).'}, {'measure': 'Sickness absence costs', 'timeFrame': '6 months', 'description': 'Sickness absence costs will be calculated based on data from the NAV registry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Risk Assessment'], 'conditions': ['Musculoskeletal Pain Disorder']}, 'referencesModule': {'references': [{'pmid': '38431296', 'type': 'DERIVED', 'citation': 'Killingmo RM, Tveter AT, Pripp AH, Tingulstad A, Maas E, Rysstad T, Grotle M. Modifiable prognostic factors of high societal costs among people on sick leave due to musculoskeletal disorders: findings from an occupational cohort study. BMJ Open. 2024 Mar 1;14(3):e080567. doi: 10.1136/bmjopen-2023-080567.'}, {'pmid': '34061299', 'type': 'DERIVED', 'citation': 'Munk Killingmo R, Tveter AT, Smastuen MC, Storheim K, Grotle M. Comparison of self-reported and public registered absenteeism among people on long-term sick leave due to musculoskeletal disorders: criterion validity of the iMTA Productivity Cost Questionnaire. Eur J Health Econ. 2021 Aug;22(6):865-872. doi: 10.1007/s10198-021-01294-0. Epub 2021 Jun 1.'}, {'pmid': '32450820', 'type': 'DERIVED', 'citation': 'Tveter AT, Oiestad BE, Rysstad TL, Aanesen F, Tingulstad A, Smastuen MC, Grotle M. Risk assessment for prolonged sickness absence due to musculoskeletal disorders: protocol for a prospective cohort study. BMC Musculoskelet Disord. 2020 May 25;21(1):326. doi: 10.1186/s12891-020-03354-7.'}]}, 'descriptionModule': {'briefSummary': 'Musculoskeletal (MSK) conditions are a leading cause of years lived with disability worldwide and for the last decade they have also been the most common cause of sickness absence and disability pension in Norway.\n\nAlthough most sickness absence is short-termed, a small proportion of people with MSK conditions are on long-term sick leave, contributing to large cost due to disbursement of benefits, productivity loss and extensive use of health care. There is growing evidence that long-term sickness absence is harmful to mental and physical health, with a reduced probability of return to work (RtW) with prolonged sickness absence. Thus, focusing on early RtW in people on sick leave due to MSK conditions is important to reduce the burden on both the individual and the society. However, to provide interventions to reduce the duration of sickness absence to all people on sick leave would require enormous resources. By targeting those at risk of long-term sickness absence, resources may be used differently, e.g. more resource-saving. By using information on modifiable risk factors from simple risk assessment tools, health care providers and other stakeholders may facilitate RtW in a better way.\n\nThe overall purposes of this project are 1) to identify the most accurate screening tool to identify people at a high risk of prolonged sickness absence due to a MSK condition, and 2) to investigate severity of MSK health, health-related quality-of-life, health care consumption, and costs across different risk profiles in people on sick leave due to MSK conditions. We will use registered data on sickness absence from 1 year before to 1 year after inclusion in the study.', 'detailedDescription': 'Main aims are:\n\n* To compare the predictive ability of the STarT MSK tool and the ÖMPSQ-SF, and other established risk factors for long-term sickness absence (e.g. symptoms of depression and emotional distress, low motivation for returning to work, low self-efficacy, work expectancies) for identifying prolonged sickness absence at 6- and 12-months follow-up due to MSK conditions\n* To develop a prognostic model to predict risk of prolonged sickness absence at 12-month follow-up in people with MSK conditions\n* To assess predictors for high costs (productivity loss and health care use) at 6- and 12-months follow-up in people on sick leave due to MSK conditions\n\nThe study will also include additional methodological and descriptive aims.\n\nPrior to the data collection we translated and culturally adapted the Keele STarT MSK and MSK-HQ following the Beaton guidelines.\n\nThe study is conducted within the Norwegian Welfare and Labor Administration (NAV) system in collaboration with OsloMet - Oslo Metropolitan University. Data on sickness absence from the NAV registry will be retrieved prospectively in the period from study inclusion to 12 months follow-up, and retrospectively 12 months prior to inclusion in the study.\n\nPrevious studies show that 30-40% of people with MSK conditions have not RtW after 3 to 12 months. In order to conduct analyses including 15- 20 predictor variables, we aim at including 500-600 people on sick leave due to MSK conditions. As the main outcomes are collected through registries, we do not expect any dropouts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People on sick leave due to musculoskeletal pain conditions in Norway were invited to participate. Eligible participants had to log on to their personal sickness absence website at the Norwegian Welfare and Labor Administration to be able to see a link to the project.', 'genderDescription': 'Female gender is a risk factor for developing musculoskeletal conditions, so we expect more women to be included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People older than 18 years on sick leave due to musculoskeletal pain for at least 4 weeks\n\nExclusion Criteria:\n\n* People on sick leave for other pain conditions or diseases\n* People not able to read or write Norwegian or English'}, 'identificationModule': {'nctId': 'NCT04196634', 'briefTitle': 'Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Oslo Metropolitan University'}, 'officialTitle': 'Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions', 'orgStudyIdInfo': {'id': 'NSD 861249'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'People on sick leave', 'description': 'People on sick leave due to musculoskeletal conditions for at least 4 weeks.', 'interventionNames': ['Other: Risk assessment']}], 'interventions': [{'name': 'Risk assessment', 'type': 'OTHER', 'description': 'People on sick leave due to musculoskeletal conditions will be screened for potential risk factors for prolonged sickness absence. No intervention will be given.', 'armGroupLabels': ['People on sick leave']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0130', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo Metropolitan University', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Margreth Grotle, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo Metropolitan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo Metropolitan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Labour and Welfare Administration', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}