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Trial record 1 of 1 for:    MI-NAV
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Effectiveness of Motivational Interviewing on Return to Work in People on Sick Leave Due to Musculoskeletal Disorders (MI-NAV)

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ClinicalTrials.gov Identifier: NCT03871712
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Norwegian Labour and Welfare Administration
Information provided by (Responsible Party):
Britt Elin Øiestad, Oslo Metropolitan University

Brief Summary:
Musculoskeletal disorders are the main causes for sickness absence and disability benefits in Norway and the leading causes of disability worldwide. There is strong evidence that long-term sickness absence due to musculoskeletal disorders provides a poor prognosis, both in terms of work-related disability, physical and mental health, and health related quality-of-life. To assist people return to work a range of vocational rehabilitation programs exist, but the initiatives have not been able to reduce the number of people who are on sick leave due to musculoskeletal disorders. In Norway, The Norwegian Labour and Welfare Administration (NAV) case-workers have taken such approaches in use, primarily by teaching their employees with user contact in how to use Motivational Interviewing (MI). However, the evidence on the effectiveness of MI on return to work is highly uncertain. The objectives of this project are to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders. All musculoskeletal diagnoses will be included. A multi-arm randomised controlled trial with 150 participants in each group will be conducted within the NAV system in Norway to evaluate these research questions.

Condition or disease Intervention/treatment Phase
Musculoskeletal Disease Musculoskeletal Pain Behavioral: Motivational interview Behavioral: Stratified vocational advice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

A multi-arm randomised controlled trial with two intervention groups and one control group doing as usual (ordinary NAV practice).

The allocation will be prepared with block randomisation for risk of long term sick leave as predicted by the Orebro Screening Questionnaire and The Keele STarT MSK Tool. Preliminary data suggests a low/medium risk group (80% of the recruited participants) and a high risk group (20%). These numbers were calculated in another study of individuals on sick leave in Norway.

Masking: Double (Investigator, Outcomes Assessor)
Masking Description:

In the written consent, the three groups will be described. Thus the participants will understand which group they are in after the first telephone call, and consequently not be blinded. The interventions are:

  1. Motivational interview by 2 meetings between participant and the NAV case-worker. Both the NAV case-workers and the participants will know that the intervention is motivational interviewing because it is only in this arm a NAV case-worker will do the intervention.
  2. Stratified vocational advice intervention (SVAI): a physiotherapist will call the study participants, and both the physiotherapist and the participants will know that they are in the SVAI intervention group from the informed consent.

The researchers will be blinded to group allocation throughout the study recruitment and assessment up to the 6-month follow-up.

Primary Purpose: Treatment
Official Title: Return to Work for People With Musculoskeletal Disorders: A Randomized Controlled Trial of the Effectiveness of Usual Case Management Alone Compared to Usual Case Management Plus Motivational Interviewing or Usual Case Management Plus Stratified Vocational Advice Intervention. The MI-NAV Study
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Experimental: Motivational Interview (MI)
In the MI arm, a NAV case worker will meet the participants after the baseline assessment (electronic questionnaires) and randomisation and conduct the MI. The NAV case-worker will either meet (or call) again after a few weeks (anticipated 2-4 weeks) and conduct another MI.
Behavioral: Motivational interview
The participants will be called twice with 2-4 weeks interval after the randomisation. This will be after 8 weeks of sick leave.

Active Comparator: Stratified vocational advice intervention (SVAI)
A trained physiotherapist will call the participants after the baseline assessment and randomisation. The SVAI intervention will be stratified due to the participants risk of long term sick leave estimated by the Orebro Screening Questionnaire and The Keele STarT MSK Tool. The low/moderate risk group will receive 1-2 phone calls, and the high risk group will be followed up 2-4 times. The follow-up can include face to face Meetings bewteen the Physical therapist and the participant, and also the employer and general practitioner when needed. The intervention will include an assessment of the participants obstacles for returning to work and help to develop and implement an action plan to overcome obstacles. The physical therapists' will cooperate with other health care providers and employer when needed.
Behavioral: Stratified vocational advice
The participants will be called after the randomisation. The amount of calls/meetings will be decided after each call, but with a maximum of 4 for the high risk group. This may include physical meetings.
Other Name: Vocational advice

No Intervention: Usual follow-up
This arm will be the control group receiving usual NAV follow-up. The other two groups will also receive usual NAV follow-up additionally to the interventions.



Primary Outcome Measures :
  1. Sickness absence days [ Time Frame: 6 months ]
    Total number of sickness absence days up to the 6-month's follow-up


Secondary Outcome Measures :
  1. Sickness absence days [ Time Frame: 12 months ]
    Total number of sickness absence days up to the 12-month's follow-up

  2. Sustainable return to work [ Time Frame: 12 months ]
    Time in months until full sustainable return to work during 12 months of follow-up, defined as 4 weeks of 100% return to original employment fraction without relapse, obtained from national registers.

  3. Medical benefits [ Time Frame: 12 months ]
    The chance of receiving medical benefits during 12 months of follow-up measured as repeated events assessed with data from national registers.

  4. Cost-utility [ Time Frame: 6 months ]
    Cost-utility at 6 months assessed by healthcare utilisation obtained from national registries. To measure treatment effects and health utilities the Euro Quality of Life 5 Dimentions 5 Levels (EQ-5D-5L) utility index will be used. The EQ-5D-5L is a generic and preference-weighted measure of health-related quality-of-life based on five dimensions: mobility, self-care, activities of daily life, pain, and anxiety and/or depression. For each dimension, the patient assesses five possible levels of problems (from no to severe, 1-5). Health gains will be expressed as quality-adjusted life years (QALYs), which will be derived from the EQ-5D-5L utility scores, using the UK tariff. QALYs range from -0.59 to 1, where 1 corresponds to perfect health, and -0.59 to worst imaginable health.

  5. Cost-utility [ Time Frame: 12 months ]
    Cost-utility at 12 months assessed by healthcare utilisation obtained from national registries. To measure treatment effects and health utilities the Euro Quality of Life 5 Dimentions 5 Levels (EQ-5D-5L) utility index will be used. The EQ-5D-5L is a generic and preference-weighted measure of health-related quality-of-life based on five dimensions: mobility, self-care, activities of daily life, pain, and anxiety and/or depression. For each dimension, the patient assesses five possible levels of problems (from no to severe, 1-5). Health gains will be expressed as quality-adjusted life years (QALYs), which will be derived from the EQ-5D-5L utility scores, using the UK tariff. QALYs range from -0.59 to 1, where 1 corresponds to perfect health, and -0.59 to worst imaginable health.

  6. Cost-effectiveness [ Time Frame: 6 months ]
    Cost-effectiveness at 6 months assessed by healthcare utilisation obtained from national registries.

  7. Cost-effectiveness [ Time Frame: 12 months ]
    Cost-effectiveness at 12 months assessed by healthcare utilisation obtained from national registries.

  8. Musculoskeletal health [ Time Frame: 12 months ]
    Musculoskeletal health will be assessed at the 12 month's follow-up with the Musculoskeletal Health Questionnaire (MSK-HQ). MSK-HQ is a new outcome questionnaire with 14 items capturing a broad variety of musculoskeletal conditions. The score provides a range from 0 to 56, with higher scores indicating better MSK health status.The MSK-HQ has undergone initial psychometric testing in four different musculoskeletal cohorts and demonstrated high completion rates, excellent test-retest reliability and strong convergent validity with other disease-specific outcomes.



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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have musculoskeletal disorders
  • Live in South-East Norway
  • Have been on sick leave for 8 weeks with a current sick-leave status of 50%-100%
  • Have a job to return to

Exclusion Criteria:

  • Have serious somatic or psychological disorders (e.g. cancer, psychotic disorders)
  • Have specific disorder requiring specialized, ongoing treatment;
  • Are pregnant
  • Are self-employed or work free lance
  • Have insufficient Norwegian or English speaking or writing skills to participate in group session and fill out questionnaire.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871712


Contacts
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Contact: Margreth Grotle, PhD +4767236043 mgrotle@oslomet.no
Contact: Britt Elin Øiestad, PhD +4767236452 brielo@oslomet.no

Locations
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Norway
Oslo Metropolitan Universtiy Recruiting
Oslo, Norway, 0130
Contact: Britt Elin Øiestad    92803089 ext 92803089    brielo@oslomet.no   
Sponsors and Collaborators
Oslo Metropolitan University
Norwegian Labour and Welfare Administration
Investigators
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Study Director: Hege Bentzen, PhD OsloMet - Oslo Metropolitan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Britt Elin Øiestad, Associate Professor, Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT03871712    
Other Study ID Numbers: The MI-NAV Study
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Musculoskeletal Pain
Musculoskeletal Diseases
Muscular Diseases
Pain
Neurologic Manifestations