Viewing Study NCT04196634


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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: Oslo Metropolitan University
Organization:

Study Overview

Official Title: Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions
Status: UNKNOWN
Status Verified Date: 2022-08
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.

Although 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.

The 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.
Detailed Description: Main aims are:

* 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
* To develop a prognostic model to predict risk of prolonged sickness absence at 12-month follow-up in people with MSK conditions
* 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

The study will also include additional methodological and descriptive aims.

Prior to the data collection we translated and culturally adapted the Keele STarT MSK and MSK-HQ following the Beaton guidelines.

The 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.

Previous 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: