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 : Active, not recruiting
First Posted : March 12, 2019
Last Update Posted : May 23, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Musculoskeletal Disease Musculoskeletal Pain||Behavioral: Motivational interview Behavioral: Stratified vocational advice||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|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)|
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:
The researchers will be blinded to group allocation throughout the study recruitment and assessment up to the 6-month follow-up.
|Official Title:||Return to Work for People With Musculoskeletal Disorders: A Randomized Controlled Trial of the Effectiveness of Usual Case Management Compared to Usual Case Management Plus Motivational Interviewing or 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|
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.
- Sickness absence days [ Time Frame: 6 months ]Total number of sickness absence days up to the 6-month's follow-up
- Sickness absence days [ Time Frame: 12 months ]Total number of sickness absence days up to the 12-month's follow-up
- 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.
- 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.
- 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.
- 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.
- Cost-effectiveness [ Time Frame: 6 months ]Cost-effectiveness at 6 months assessed by healthcare utilisation obtained from national registries.
- Cost-effectiveness [ Time Frame: 12 months ]Cost-effectiveness at 12 months assessed by healthcare utilisation obtained from national registries.
- 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|
- 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
- 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.
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
|Oslo Metropolitan Universtiy|
|Oslo, Norway, 0130|
|Study Director:||Hege Bentzen, PhD||OsloMet - Oslo Metropolitan University|
Documents provided by Britt Elin Øiestad, Oslo Metropolitan University:
|Responsible Party:||Britt Elin Øiestad, Associate Professor, Oslo Metropolitan University|
|Other Study ID Numbers:||
The MI-NAV Study
|First Posted:||March 12, 2019 Key Record Dates|
|Last Update Posted:||May 23, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|