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| ID | Type | Description | Link |
|---|---|---|---|
| 315041 | Other Grant/Funding Number | The Research Council of Norway |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmaRTWork | Experimental | This group receives the SmaRTWork intervention in addition to usual care |
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| Usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmaRTWork | Behavioral | 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 in contact with a caseworker at the social insurance office. The intervention is given in addition to usual care. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to sustainable return-to-work (RTW) | 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 | 12 months from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sickness absence days | Total number of sickness absence days during 12 months of follow-up from randomization based on registry data | 12 months from randomization |
| Probability of working each month |
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Inclusion Criteria:
Exclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lene Aasdahl, MD PhD | Contact | +47 93224342 | lene.aasdahl@ntnu.no | |
| Paul J Mork, PhD | Contact | +47 90104615 | paul.mork@ntnu.no |
| Name | Affiliation | Role |
|---|---|---|
| Lene Aasdahl, MD PhD | Norwegian University of Science and Technology | Principal Investigator |
| Solveig K Grudt, Head of Department | Norwegian University of Science and Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norwegian University of Science and Technology | Trondheim | 7027 | Norway |
Due to the ethical consent data cannot be shared.
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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The probability of working (i.e., not receiving medical benefits) each month during 12 months of follow-up, measured as repeated events
| 12 months from randomization |
| Musculoskeletal Health Questionnaire (MSK-HQ) | Questionnaire that measures musculoskeletal health with scores from 0 to 56 points, with higher scores indicating better musculoskeletal health | From randomization to 12 months of follow-up |
| Health-related quality of life | Assessed by the EuroQol 5-dimension questionnaire, weighted according to the Danish value set (range, 0-1, with higher scores indicating better health status) and the EuroQol visual analog scale (range, 0-100, with higher scores indicating better health status) | 12 months from randomization |
| Average pain last week | Measured by a numeric rating scale scores from 0 (no pain) to 10 (worst imaginable pain) | 12 months from randomization |
| Pain Self-Efficacy | Ability to cope despite pain as assessed with the Pain Self-Efficacy Questionnaire (PSEQ), range, 0-60, with higher scores indicating greater confidence | 12 months from randomization |
| Depressive symptoms | Depressive symptoms by the Patient Health Questionnaire-2 (PHQ-2), scores range from 0-6 (higher more symptoms) | 12 months from randomization |
| Brief Illness Perception | Cognitive and emotional perceptions of illness assessed by the Brief Illness Perception Questionnaire (range, 0-80, with higher scores indicating greater illness perception) | 12 months from randomization |
| Work ability | Work ability measured by the single item from the Work Ability Index (WAI) scored from 0 (worst) to 10 (best). | 12 months from randomization |
| Overall improvement | Assessed by the Global Perceived Effect scale. Range, -5 to 5, with positive scores indicating improvement of pain | 12 months from randomization |
| Fear avoidance beliefs | Measured by one-item from Tampa Scale of Kinesiophobia scored from 0 (no fear) to 10 (much fear) | 12 months from randomization |
| Stress | Measured by the Perceived Stress Scale, scored from 0 to 40, with higher scores indicating greater perceived stress | 12 months from randomization |
| Insomnia | Measured by items from the The Trøndelag Health Study (HUNT) populations study | 12 months from randomization |