NCT02945397

Brief Summary

The study compares the effect of a group-based activity with an individual work-out activity on work participation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

4.2 years

First QC Date

September 30, 2016

Last Update Submit

September 28, 2019

Conditions

Musculoskeletal PainWork Related IllnessesBurnout, Professional

Keywords

Return to workWork rehabilitationSick-leave

Outcome Measures

Primary Outcomes (1)

  • Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases.

    7 years

Secondary Outcomes (11)

  • Subjective health complaints measured through questionnaire data.

    15 months

  • Fatigue measured through questionnaire data.

    15 months

  • Self-rated health measured through questionnaire data.

    15 months

  • Sleep measured through questionnaire data.

    15 months

  • Alcohol use measured through questionnaire data.

    15 months

  • +6 more secondary outcomes

Study Arms (2)

Individual activity

ACTIVE COMPARATOR

The individual activity consists of a 3 month membership card at a given gym. This is in addition to regular follow-up from welfare authorities.

Behavioral: Individual activity

Group-based activity

ACTIVE COMPARATOR

The group-based activity consists of a 3 month group activity with weekly gatherings, focusing on coping, goal-setting and relevant information regarding available public services. This is in addition to regular follow-up from welfare authorities.

Behavioral: Group-based activity

Interventions

Group-based activityBEHAVIORAL

Regular follow-up from welfare authority as well as a 3 month group activity with weekly gatherings, focusing on coping, goal-setting and relevant information regarding available public services.

Group-based activity
Individual activityBEHAVIORAL

Regular follow-up from welfare authority as well as a 3 month membership card at a given gym.

Individual activity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Desire to work
  • Understand Norwegian sufficiently to complete surveys

You may not qualify if:

  • Not able to participate in the interventions due to personal or health-related constraints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uni Research

Bergen, 5014, Norway

Location

MeSH Terms

Conditions

Musculoskeletal PainBurnout, Professional

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOccupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Torill Tveito

    Uni Research Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 26, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)