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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05575908
Other study ID # 2021/11991
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 13, 2022
Est. completion date September 2026

Study information

Verified date November 2023
Source St. Olavs Hospital
Contact Gunn Hege Marchand, PhD
Phone +4772822337
Email gunn.hege.marchand@ntnu.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Long-term sick leave is a challenge in Norway, and the healthcare and labor- and welfare services are often not coordinated in helping the sick-listed employees return to work. In this study, the investigators want to evaluate the effectiveness of an intervention where an expert team provides advice for an individualized patient pathway based on information from a digital questionnaire and a video meeting with the sick-listed employee and the participant's general practitioner. The patient pathway should include both healthcare and labor- and welfare services measures. Sick-listed patients with musculoskeletal- and/or common mental disorders are invited to join the study. They will receive a digital questionnaire and be randomized to either treatment as usual or personalized advice from an expert team. The team will be put together based on the response from the individual's questionnaire. The investigators will evaluate the effect on return to work and the use of health care services 12 months after the intervention.


Recruitment information / eligibility

Status Recruiting
Enrollment 170
Est. completion date September 2026
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Sick-listed minimum 50% between 11 and 20 weeks - Musculoskeletal disorder and/or common mental disorder - Living in the county of Trøndelag or Møre- og Romsdal Exclusion Criteria: - Specific conditions such as fracture, trauma, infections, malignancy, dislocations, etc. - Serious mental conditions or another serious disease that makes participation difficult - Most likely to return to work within 2 weeks - Not speaking/reading Norwegian

Study Design


Intervention

Procedure:
Digital expert team
A digital team will be appointed based on the participant's answers in the digital screening questionnaire. Members of the team can be specialists in Physical and rehabilitation medicine, psychologist, physiotherapist, social workers, and consultants in the labor- and welfare administration. The general practitioner will also be invited to the meeting.

Locations

Country Name City State
Norway Ålesund sjukehus Ålesund Midt-Norge
Norway Sykehuset Levanger Levanger Midt-Norge
Norway Molde Sjukehus Molde Midt-Norge
Norway St. Olavs hospital HF Trondheim Midt-Norge

Sponsors (2)

Lead Sponsor Collaborator
St. Olavs Hospital Norwegian Labour and Welfare Administration

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Sleep quality and insomnia Prevalence of insomnia and bad sleep quality and change after 12 months. Measured with Insomnia severity index (ISI). ISI is scored on a range from 0-4, with higher score indicating more serious symptoms. 12 months
Primary Return to work Time to return to work within 12 months for at least 4 consecutive weeks 12 months
Secondary Function Approvement in function measured by Versus Arthritis Musculoskeletal Health Questionnaire (MSK-HQ). The MSK-HQ is scored on a range of 0-56, with a better score indicating better MSK-HQ health status 12 months
Secondary Change in pain Change in pain measured on a numeric rating scale (0-10), with a higher score indicating more pain 12 months
Secondary Change in depression symptoms Improvement in depression symptoms measured by Patient Health Questionnaire-9 (PHQ-9). PHQ-9 is scored on a range of 0-27, with higher score indicating more serious symptoms 12 months
Secondary Change in anxiety symptoms Improvement in anxiety symptoms measured by Generalized Anxiety Disorder 7-item (GAD-7). GAD-7 is scored on a range of 0-21, with higher score indicating more serious symptoms 12 months
Secondary Days lost from work Lost workdays during one year after intervention 12 months
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