SmaRTWork - a Decision Support System to Promote Return to Work Among People Sick-listed With Musculoskeletal Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Time to sustainable return-to-work (RTW)
研究概览
简要总结
The objective of this study is to evaluate the effect of an intervention, SmaRTWork, on return to work compared to usual care for individuals who are sick-listed due to musculoskeletal disorders. Potential participants are individuals of working age (20-59 years) sick-listed due to a musculoskeletal disorder (neck pain, low back pain, or widespread pain) for up to 12 weeks living in Norway. The primary outcome will be time to sustainable return to work. We will also evaluate the effect on other work outcomes and health outcomes. We will also interview participants and stakeholders about their experience with the intervention.
详细描述
The objective of this study is to determine the effectiveness of SmaRTWork (intervention) on return to work (RTW) compared to usual care (comparator) for individuals sick-listed due to musculoskeletal disorders. The study is designed as a single-blinded randomised controlled trial (RCT) with two parallel groups. Individuals of working age (20-59 years) sick-listed due to a musculoskeletal disorder (neck pain, low back pain, or widespread pain) for up to 12 weeks living in Norway are eligible for the study. Potential participants are identified and informed about the project by their general practitioner. We plan to include a total of 298 participants in the trial (and 15-20 in a pilot, giving a total of 318). The primary outcome will be time to sustainable RTW, i.e., one month without receiving sickness benefits, during the 12 months of follow-up based on registry data. Secondary outcomes include other work outcomes and health outcomes. Along with the RCT we will also conduct qualitative studies and a process evaluation. If the SmaRTWork turns out to be effective on RTW, we will also perform a health economic evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals 20-59 years old (working age)
- •Living in Norway
- •Own a smart phone with internet access
- •Sick-listed due to a musculoskeletal disorder for up to 12 weeks
- •The main diagnosis for sick leave is back pain, neck pain or widespread pain. For example one of the following (ICPC-2 diagnoses codes): Neck symptom/complaint (L01), Back symptom/complaint (L02), Low back symptom/complaint (L03), Muscle pain (L18), Back syndrome without radiating pain (L84)
排除标准
- •No employer (unemployed or self-employed)
- •Poor Norwegian comprehension
- •Sick listed for more than 3 months the previous 12 months
- •Have a planned date for RTW during the next week
- •previous participation in the trial or concurrent participation in another study that could interfere with the current trial
- •Unable to take part in exercise/physical activity (e.g., use of walking aids, unable to get up and down on the floor independently)
- •Leg pain worse than back pain
- •Red flags that could indicate serious underlying pathology:
- •Changes in bladder or bowel function
- •General feeling of being unwell (malaise), fever and/or unexplained weight loss
- •Reduced muscle (motor) function, sensory loss, walking problems or balance problems
- •Neck or back pain that started after the age of 55 or feel different from previous pain episodes
- •Pain that does not improve with rest or light activity or pain that is much worse during the night
- •Previous or ongoing cancer
- •Use of steroids/immune suppressing medications or drug use
- •Pain that is trauma (injury) related
- •Serious ongoing somatic (e.g., unstable heart disease) or mental disorder (e.g., psychosis, ongoing manic episode, suicidal ideation)
- •Pain has not been assessed by a clinician
研究组 & 干预措施
Usual care
The participants receive usual care as if they were not part of any study. There are no restrictions on what they can or cannot do.
SmaRTWork
This group receives the SmaRTWork intervention in addition to usual care
干预措施: SmaRTWork (Behavioral)
结局指标
主要结局
Time to sustainable return-to-work (RTW)
时间窗: 12 months from randomization
Time to sustainable return-to-work (RTW), i.e., one month without receiving sickness benefits, during the 12 months of follow-up from randomization based on registry data
次要结局
- Stress(12 months from randomization)
- Insomnia(12 months from randomization)
- Number of sickness absence days(12 months from randomization)
- Probability of working each month(12 months from randomization)
- Musculoskeletal Health Questionnaire (MSK-HQ)(From randomization to 12 months of follow-up)
- Health-related quality of life(12 months from randomization)
- Average pain last week(12 months from randomization)
- Pain Self-Efficacy(12 months from randomization)
- Depressive symptoms(12 months from randomization)
- Brief Illness Perception(12 months from randomization)
- Work ability(12 months from randomization)
- Overall improvement(12 months from randomization)
- Fear avoidance beliefs(12 months from randomization)