NCT05575908

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Oct 2022Dec 2026

First Submitted

Initial submission to the registry

September 21, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

October 13, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

3.2 years

First QC Date

September 21, 2022

Last Update Submit

May 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Return to work

    Time to return to work within 12 months for at least 4 consecutive weeks

    12 months

Secondary Outcomes (5)

  • Function

    12 months

  • Change in pain

    12 months

  • Change in depression symptoms

    12 months

  • Change in anxiety symptoms

    12 months

  • Days lost from work

    12 months

Other Outcomes (1)

  • Sleep quality and insomnia

    12 months

Study Arms (2)

Digital expert team

EXPERIMENTAL

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.

Procedure: Digital expert team

Treatment as usual

NO INTERVENTION

The participants will answer a digital questionnaire and will get normal follow-up from his/her general practitioner and labor- and welfare administration (NAV).

Interventions

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.

Digital expert team

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Ålesund sjukehus

Ålesund, Midt-Norge, 6017, Norway

Location

Sykehuset Levanger

Levanger, Midt-Norge, 7600, Norway

Location

Molde Sjukehus

Molde, Midt-Norge, 6412, Norway

Location

St. Olavs hospital HF

Trondheim, Midt-Norge, 7006, Norway

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesMental Disorders

Study Officials

  • Gunn Hege Marchand, PhD

    St. Olavs hospital HF

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is not possible to blind the participants or the care providers. As the investigators also will be care providers in this study, they will also have knowledge of the allocation. After the intervention, all data will be depersonalized and the name and other identifiers will be replaced by a study number. The outcome will be collected from national registries and the merging of data will be done by a statistician in the labor- and welfare administration who is not involved in the assessment of data. This allows the researchers to be blinded when they analyze the data.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Sick-listed employees with musculoskeletal disorders and/or common mental disorders will receive an invitation to the study from the labor-and welfare administration. Individuals who consent to participate will be allocated to either treatment as usual or personalized advice from an expert-team.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

October 12, 2022

Study Start

October 13, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations