- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575908
Expert@Work - Effectiveness of a Digital Expert Team on Return to Work (Expert@Work)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Midt-Norge
-
Levanger, Midt-Norge, Norway, 7600
- Sykehuset Levanger
-
Molde, Midt-Norge, Norway, 6412
- Molde Sjukehus
-
Trondheim, Midt-Norge, Norway, 7006
- St. Olavs hospital HF
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Ålesund, Midt-Norge, Norway, 6017
- Alesund sjukehus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital expert team
The participants allocated to this arm will receive personalized advice from an expert team.
The participants will have one video meeting with the team and receive a written report.
|
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.
|
|
No Intervention: Treatment as usual
The participants will answer a digital questionnaire and will get normal follow-up from his/her general practitioner and labor- and welfare administration (NAV).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return to work
Time Frame: 12 months
|
Time to return to work within 12 months for at least 4 consecutive weeks
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Function
Time Frame: 12 months
|
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
|
|
Change in pain
Time Frame: 12 months
|
Change in pain measured on a numeric rating scale (0-10), with a higher score indicating more pain
|
12 months
|
|
Change in depression symptoms
Time Frame: 12 months
|
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
|
|
Change in anxiety symptoms
Time Frame: 12 months
|
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
|
|
Days lost from work
Time Frame: 12 months
|
Lost workdays during one year after intervention
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality and insomnia
Time Frame: 12 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Gunn Hege Marchand, PhD, St. Olavs hospital HF
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/11991
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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