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临床试验/NCT04196634
NCT04196634Unknown不适用

Risk Assessment for Prolonged Sickness Absence Due to Musculoskeletal Conditions

Oslo Metropolitan University1 个研究点 分布在 1 个国家目标入组 560 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
560
试验地点
1
主要终点
Sickness absence days

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • People older than 18 years on sick leave due to musculoskeletal pain for at least 4 weeks

排除标准

  • People on sick leave for other pain conditions or diseases
  • People not able to read or write Norwegian or English

结局指标

主要结局

Sickness absence days

时间窗: 12 months

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

Time to sustainable return to work

时间窗: 12 months

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

Sickness absence costs

时间窗: 12 months

Sickness absence costs will be calculated based on data from the NAV registry

Probability of return to work

时间窗: 12 months

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

Proportion who have returned to work

时间窗: 12 months

Proportion of people with sustainable return to work (at least 4 weeks) at 12 months. Register data from the national health and welfare services

Health care costs

时间窗: 12 months

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).

次要结局

  • Sickness absence costs(6 months)
  • Institute of Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ)(Baseline and 4 weeks)
  • Probability of return to work(6 months)
  • Sickness absence days(6 months)
  • Proportion who have returned to work(6 months)
  • Musculoskeletal Health Questionnaire (MSK-HQ)(Baseline and 4 weeks)
  • Health care costs(6 months)
  • EuroQol 5 Dimensions (EQ5D-5L)(Baseline and 4 weeks)
  • Time to sustainable return to work(6 months)

研究者

发起方
Oslo Metropolitan University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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