Norwegian University of Science and Technology
Trondheim, 7027, Norway
Location contact
Lene Aasdahl, MD PhD
CONTACT
Lene Aasdahl, MD PhD
PRINCIPAL_INVESTIGATOR
Paul J Mork, PhD
CONTACT
NCT Number: NCT07034040
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.
Trial opening soon.
Get Notified20 year–59 year
All sexes
Interventional
Not applicable
Trondheim, 7027, Norway
Lene Aasdahl, MD PhD
CONTACT
Lene Aasdahl, MD PhD
PRINCIPAL_INVESTIGATOR
Paul J Mork, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 12 months from randomization
Total number of sickness absence days during 12 months of follow-up from randomization based on registry data
Time frame: 12 months from randomization
The probability of working (i.e., not receiving medical benefits) each month during 12 months of follow-up, measured as repeated events
Time frame: From randomization to 12 months of follow-up
Questionnaire that measures musculoskeletal health with scores from 0 to 56 points, with higher scores indicating better musculoskeletal health
Time frame: 12 months from randomization
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)
Time frame: 12 months from randomization
Measured by a numeric rating scale scores from 0 (no pain) to 10 (worst imaginable pain)
Time frame: 12 months from randomization
Ability to cope despite pain as assessed with the Pain Self-Efficacy Questionnaire (PSEQ), range, 0-60, with higher scores indicating greater confidence
Time frame: 12 months from randomization
Depressive symptoms by the Patient Health Questionnaire-2 (PHQ-2), scores range from 0-6 (higher more symptoms)
Time frame: 12 months from randomization
Cognitive and emotional perceptions of illness assessed by the Brief Illness Perception Questionnaire (range, 0-80, with higher scores indicating greater illness perception)
Time frame: 12 months from randomization
Work ability measured by the single item from the Work Ability Index (WAI) scored from 0 (worst) to 10 (best).
Time frame: 12 months from randomization
Assessed by the Global Perceived Effect scale. Range, -5 to 5, with positive scores indicating improvement of pain
Time frame: 12 months from randomization
Measured by one-item from Tampa Scale of Kinesiophobia scored from 0 (no fear) to 10 (much fear)
Time frame: 12 months from randomization
Measured by the Perceived Stress Scale, scored from 0 to 40, with higher scores indicating greater perceived stress
Time frame: 12 months from randomization
Measured by items from the The Trøndelag Health Study (HUNT) populations study. Higher scores worse. Items can be combined to approximate classification of insomnia diagnosis
Contact information is provided by the study sponsor or research team.
Lene Aasdahl, MD PhD
CONTACT
Paul J Mork, PhD
CONTACT
Norwegian University of Science and Technology
Other
Acronym: SmaRTWork
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07606261
Absenteeism, Behavior
Bandol, France
View Trial DetailsNCT05772494
Mental Disorders, Sick Leave
Gothenburg, Sweden
View Trial DetailsNCT06398860
Cost-effectiveness, Occupational Health
Falun, Sweden
View Trial DetailsNCT04130126
Sick Leave
Basel, Switzerland
View Trial Details