Musculoskeletal PainNCT02945397
Effect Evaluation of the Work Rehabilitation Effort "Best iLag"
A study testing Group-based activity and Individual activity in people with Musculoskeletal Pain and Work Related Illnesses, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
Trial summary
The study compares the effect of a group-based activity with an individual work-out activity on work participation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain, Work Related Illnesses, Burnout, Professional
- What is being tested?
- Group-based activity and Individual activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2015to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Desire to work
- Understand Norwegian sufficiently to complete surveys
Who cannot join
- Not able to participate in the interventions due to personal or health-related constraints.
Trial locations and contacts
1 site in 1 country.
About this study
The study compares the effect of a group-based activity with an individual work-out activity on work participation.
Read the detailed description
The study is an RCT comparing the effect of a group-based intervention with an individual work-out intervention on work participation. The target group is persons who are at risk of leaving the work force due to health issues, and people currently outside the work force. The interventions have a time-span of 3 months. Survey data will be collected at baseline, after three months (after intervention has ended), and after 15 months. Survey data include information on lifestyle, self-reported health, subjective health complaints and readiness for work. Register data on employment and welfare benefits will be collected from two years in advance of inclusion, and five years after inclusion. According to power calculations, the study will need 322 participants.
In addition to the effect evaluation, a process evaluation will also be performed. The process evaluation will examine content quality and adherence to guidelines, as well as feasibility of the group intervention. The process evaluation will consist of some survey data as well as interviews with service providers and participants.
- Being tested
- Group-based activity, Individual activity
- Keywords
- Return to work, Work rehabilitation, Sick-leave
- Medical subject headings
- Musculoskeletal Pain, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based activityBehavioural
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.
Individual activityBehavioural
Regular follow-up from welfare authority as well as a 3 month membership card at a given gym.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Group-based activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases.
Measured: 7 years
Secondary outcomes (11)
Subjective health complaints measured through questionnaire data.
Subjective health complaints inventory
Measured: 15 months
Fatigue measured through questionnaire data.
Chalder fatigue questionnaire
Measured: 15 months
Self-rated health measured through questionnaire data.
Global health question
Measured: 15 months
Sleep measured through questionnaire data.
Sleep (single items)
Measured: 15 months
Alcohol use measured through questionnaire data.
The Alcohol Use Disorders Identification Test
Measured: 15 months
Quality of life measured through questionnaire data.
EQ-5D (Health-related quality of life + visual analogue scale)
Measured: 15 months
Regular exercise measured through questionnaire data.
Regular exercise (single items)
Measured: 15 months
Bullying measured through questionnaire data.
Bullying (single items)
Measured: 15 months
Social support measured through questionnaire data.
Non-directive and Directive Support Survey
Measured: 15 months
Coping measured through questionnaire data.
Theoretically Originated Measure of Cognitive Activation Theory of Stress
Measured: 15 months
Work readiness measured through questionnaire data.
Readiness for Return to Work Scale.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startJan 2015
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Responsible party
- Sponsor
- Investigators
- Torill Tveito, Principal investigator, Uni Research Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945397
- Sponsor's protocol ID
- Best iLag
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2016
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Evaluation of the Work Rehabilitation Effort "Best iLag"
- ClinicalTrials.gov ID
- NCT02945397
- Acronym / sponsor ID
- Best iLag
- Keywords
- Return to work, Work rehabilitation, Sick-leave
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- Norwegian Labour and Welfare Administration
- Study start
- Jan 2015 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares the effect of a group-based activity with an individual work-out activity on work participation.
Detailed description
The study is an RCT comparing the effect of a group-based intervention with an individual work-out intervention on work participation. The target group is persons who are at risk of leaving the work force due to health issues, and people currently outside the work force. The interventions have a time-span of 3 months. Survey data will be collected at baseline, after three months (after intervention has ended), and after 15 months. Survey data include information on lifestyle, self-reported health, subjective health complaints and readiness for work. Register data on employment and welfare benefits will be collected from two years in advance of inclusion, and five years after inclusion. According to power calculations, the study will need 322 participants.
In addition to the effect evaluation, a process evaluation will also be performed. The process evaluation will examine content quality and adherence to guidelines, as well as feasibility of the group intervention. The process evaluation will consist of some survey data as well as interviews with service providers and participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual activity | Active comparator | Behavioral: Individual activityThe individual activity consists of a 3 month membership card at a given gym. This is in addition to regular follow-up from welfare authorities. |
| Group-based activity | Active comparator | Behavioral: Group-based activityThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Desire to work
- Understand Norwegian sufficiently to complete surveys
Key exclusion criteria (1 listed)
- Not able to participate in the interventions due to personal or health-related constraints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based activityRegular 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. | Behavioural | Group-based activity |
| Individual activityRegular follow-up from welfare authority as well as a 3 month membership card at a given gym. | Behavioural | Individual activity |
Primary outcome
Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases.
Time frame: 7 years
11 secondary outcomes
Subjective health complaints measured through questionnaire data.
Time frame: 15 months
Fatigue measured through questionnaire data.
Time frame: 15 months
Self-rated health measured through questionnaire data.
Time frame: 15 months
Sleep measured through questionnaire data.
Time frame: 15 months
Alcohol use measured through questionnaire data.
Time frame: 15 months
Quality of life measured through questionnaire data.
Time frame: 15 months
Regular exercise measured through questionnaire data.
Time frame: 15 months
Bullying measured through questionnaire data.
Time frame: 15 months
Social support measured through questionnaire data.
Time frame: 15 months
Coping measured through questionnaire data.
Time frame: 15 months
Work readiness measured through questionnaire data.
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torill Tveito principal investigator
Uni Research Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based activity and Individual activity in people with Musculoskeletal Pain and Work Related Illnesses, run by NORCE Norwegian Research Centre AS at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days at work during follow-up period measured through data from the Norwegian Labour and Welfare Administration´s databases. (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.