SmaRTWork - a Decision Support System to Promote Return to Work Among People Sick-listed With Musculoskeletal Disorders

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое SmaRTWork
  The SmaRTWork app provides weekly individually tailored self-management plans by matching the participant's health information and sick leave status with targeted educational messages, physical activity advice, and exercise recommendations. In addition, participants with specific problems regarding i) work accommodations, ii) workplace conflicts, iii) large responsibilities as caregivers, iv) financial problems, or v) who do not think they will return to the old workplace are offered to be set i

Первичные конечные точки

• Time to sustainable return-to-work (RTW) [Срок оценки: 12 months from randomization]

Вторичные конечные точки (12)

• Number of sickness absence days [Срок оценки: 12 months from randomization]
• Probability of working each month [Срок оценки: 12 months from randomization]
• Musculoskeletal Health Questionnaire (MSK-HQ) [Срок оценки: From randomization to 12 months of follow-up]
• Health-related quality of life [Срок оценки: 12 months from randomization]
• Average pain last week [Срок оценки: 12 months from randomization]
• Pain Self-Efficacy [Срок оценки: 12 months from randomization]
• Depressive symptoms [Срок оценки: 12 months from randomization]
• Brief Illness Perception [Срок оценки: 12 months from randomization]
• Work ability [Срок оценки: 12 months from randomization]
• Overall improvement [Срок оценки: 12 months from randomization]
• Fear avoidance beliefs [Срок оценки: 12 months from randomization]
• Stress [Срок оценки: 12 months from randomization]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• Pregnant
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Норвегия · 1 центр

• Norwegian University of Science and Technology — Trondheim

Идентификаторы

NCT: NCT07034040 · 563919 · 315041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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