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Expert@Work - Effectiveness of a Digital Expert Team on Return to Work (Expert@Work)

Primary Purpose

Musculoskeletal Diseases, Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Digital expert team
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Diseases

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sykehuset LevangerRecruiting
  • Molde SjukehusRecruiting
  • St. Olavs hospital HFRecruiting
  • Ålesund sjukehusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Digital expert team

Treatment as usual

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in pain
Change in pain measured on a numeric rating scale (0-10), with a higher score indicating more pain
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
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
Days lost from work
Lost workdays during one year after intervention

Full Information

First Posted
September 21, 2022
Last Updated
November 22, 2022
Sponsor
St. Olavs Hospital
Collaborators
Norwegian Labour and Welfare Administration
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1. Study Identification

Unique Protocol Identification Number
NCT05575908
Brief Title
Expert@Work - Effectiveness of a Digital Expert Team on Return to Work
Acronym
Expert@Work
Official Title
Expert@Work - Effectiveness of a Digital Expert Team on Return to Work
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian Labour and Welfare Administration

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases, Mental Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital expert team
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
The participants will answer a digital questionnaire and will get normal follow-up from his/her general practitioner and labor- and welfare administration (NAV).
Intervention Type
Procedure
Intervention Name(s)
Digital expert team
Intervention Description
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.
Primary Outcome Measure Information:
Title
Return to work
Description
Time to return to work within 12 months for at least 4 consecutive weeks
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Function
Description
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
Time Frame
12 months
Title
Change in pain
Description
Change in pain measured on a numeric rating scale (0-10), with a higher score indicating more pain
Time Frame
12 months
Title
Change in depression symptoms
Description
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
Time Frame
12 months
Title
Change in anxiety symptoms
Description
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
Time Frame
12 months
Title
Days lost from work
Description
Lost workdays during one year after intervention
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Sleep quality and insomnia
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gunn Hege Marchand, PhD
Phone
+4772822337
Email
gunn.hege.marchand@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Janne-Birgitte Børke, Msc
Phone
+4772822337
Email
janne-birgitte.borke@stolav.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunn Hege Marchand, PhD
Organizational Affiliation
St. Olavs hospital HF
Official's Role
Study Director
Facility Information:
Facility Name
Sykehuset Levanger
City
Levanger
State/Province
Midt-Norge
ZIP/Postal Code
7600
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janne-Birgitte Børke, MSc
Phone
+4772822337
Email
Janne-Birgitte.Borke@stolav.no
Facility Name
Molde Sjukehus
City
Molde
State/Province
Midt-Norge
ZIP/Postal Code
6412
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Sletnes
Phone
+4772120508
Facility Name
St. Olavs hospital HF
City
Trondheim
State/Province
Midt-Norge
ZIP/Postal Code
7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunn Hege Marchand, PhD
Phone
+4772822337
Email
gunn.hege.marchand@ntnu.no
First Name & Middle Initial & Last Name & Degree
Janne-Birgitte Børke, MSc
Phone
+4772822337
Email
Janne-Birgitte.Borke@stolav.no
Facility Name
Ålesund sjukehus
City
Ålesund
State/Province
Midt-Norge
ZIP/Postal Code
6017
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eivind Marstein
Phone
+4770105751
Email
eivind.marstein@helse-mr.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Expert@Work - Effectiveness of a Digital Expert Team on Return to Work

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