Workers on Sick-leave, Insured by The Danish Welfare StatejosNCT02136056
Effects of a Self-management Course for Adults on Sick-leave
A study testing Self-management program (SMP) in people with Workers on Sick-leave, Insured by The Danish Welfare State, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the current study is to determine the efficacy of a self-management course for workers on sick-leave as an add-on to standard rehabilitation care and follow-up (treatment as usual). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Workers on Sick-leave, Insured by The Danish Welfare State
- What is being tested?
- Self-management program (SMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to 1 Aug 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Insured persons who receive sick-leave compensation from the Danish State
- Persons who are listed as sick from a job
- Persons who have been categorized as "2 - risk" or "3 - chronic" case by the job-center
- The health problem reflects a chronic or a long-term condition
- The person acknowledges a chronic or long-term condition
- The person wants to work with his or her condition
- The person wants to return to work
- The person volunteers to participate
Who cannot join
- Persons who are listed sick for more than 16 weeks
- Persons who are categorized as "1 - easy" by the job-center
- The person does not understand or speak danish
- History or signs of aggressive behavior and violence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Self-management Course for Adults on Sick-leave; Outcomes in Registry Based Measures of Return to Work and Questionnaire Based Measures of Well-being and Quality of Life
The purpose of the current study is to determine the efficacy of a self-management course for workers on sick-leave as an add-on to standard rehabilitation care and follow-up (treatment as usual). Outcomes are registry based measures of return to work, and questionnaire based measures of well-being and quality of life.
We thus, hypothesize that the program will improve workers return to work rates and self-reported/psychological well-being.
Read the detailed description
The intervention course is a Danish adaptation of The Chronic Disease Self-Management Program (CDSMP), tailored towards workers on sick-leave. The original program has been developed by The Stanford Patient Education Research Center. The translation and adaptation has been conducted by The Danish Committee for Health Education.
Previous studies have examined the program with respect to specific chronic diseases (e.g., Arthritis), quality of life, well-being and health-care utilization, though non-otherwise specified workers on sick-leave and return work have not been examined before.
The framework of CDSMP is social-cognitive learning theory in which self-efficacy plays a central role.
- Being tested
- Self-management program (SMP)
- Keywords
- Sick-leave, Return to work, Self-management, Self-efficacy, Quality of Life and Well-being, Motivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management program (SMP)Behavioural
Also called Stanford patient education
A self-management course
| Study group | Role | What they receive |
|---|---|---|
| Self-management program (SMP) | Experimental | Participants in the experimental group receive six weekly group-sessions of self-management and patient education; specifically targeting self-management of the return to work process and disease symptoms. Receives: Behavioral: Self-management program (SMP) |
| Treatment as usual | No intervention | Participants in the control-group receive standard rehabilitation care and follow-up in the job-center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to work, duration
DREAM-registry (supported by the Danish Ministry of Employment) combined with income/employment information from e-income (supported by the Danish Tax Authorities).
Measured: Weekly from baseline till 1 year follow-up
Well-being and Quality of life
WHO-5 Well-being and WHO Quality of Life/Satisfaction items (Bech, 2012)
Measured: up to 5 month follow-up
Secondary outcomes (5)
Common mental disorders
The CMDQ questionnaire i based on SCL-90 (Symptom Checklist) and measures somatization, health-anxiety, depression, anxiety and alcohol consumption (Christensen et al., 2005)
Measured: Baseline, post-intervention and 4,5 month follow-up
Disease self-efficacy scale
The University of Washington Self-efficacy scale, 6 item version (Amtmann et al., 2012)
Measured: Baseline, post-intervention and 4,5 month follow-up
Self-regulation (return to work)
Return to work self-regulation questionnaire, measuring internalization of reasons for trying to return to work; adapted from the Treatment Self-regulation Questionnaire (Levesque et al., 2007)
Measured: Baseline, post-intervention and 4,5 month follow-up
Self-management scale
A measure of six cognitive strategies which are taught at the course (Lorig et al., 1996)
Measured: Baseline, post-intervention and 4,5 month follow-up
Illness Perception questionnaire
A measure of 8 items measuring the threat of illness or disease (B-IPQ; Broadbent, Petrie, Main \& Weinman, 2006)
Measured: Baseline, post-intervention and 4,5 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startSep 2014
- Primary completion1 Jun 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Workers on Sick-leave, Insured by The Danish Welfare StateStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, VIVE - The Danish Center for Social Science Research
- Responsible party
- Sponsor
- Investigators
- Martin H Olesen, PhD, Study director, Aarhus University and Aarhus University HospitalJan Høgelund, PhD, Study chair, VIVE - The Danish Center for Social Science ResearchMimi Y Mehlsen, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136056
- Sponsor's protocol ID
- auh_JOS_sfi-01
- Acronym
- jos
- Status last verified
- Sep 2016
- First submitted
- 8 May 2014
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bech, P. Clinical Psychometrics. Oxford: Wiley-Blackwell, 2012.
Christensen KS, Fink P, Toft T, Frostholm L, Ornbol E, Olesen F. A brief case-finding questionnaire for common mental disorders: the CMDQ. Fam Pract. 2005 Aug;22(4):448-57. doi: 10.1093/fampra/cmi025. Epub 2005 Apr 6.
PubMed 15814580Bjorner JB, Damsgaard MT, Watt T, Groenvold M. Tests of data quality, scaling assumptions, and reliability of the Danish SF-36. J Clin Epidemiol. 1998 Nov;51(11):1001-11. doi: 10.1016/s0895-4356(98)00092-4.
PubMed 9817118Amtmann D, Bamer AM, Cook KF, Askew RL, Noonan VK, Brockway JA. University of Washington self-efficacy scale: a new self-efficacy scale for people with disabilities. Arch Phys Med Rehabil. 2012 Oct;93(10):1757-65. doi: 10.1016/j.apmr.2012.05.001. Epub 2012 May 7.
PubMed 22575393Franche RL, Krause N. Readiness for return to work following injury or illness: conceptualizing the interpersonal impact of health care, workplace, and insurance factors. J Occup Rehabil. 2002 Dec;12(4):233-56. doi: 10.1023/a:1020270407044.
PubMed 12389476Nieuwenhuijsen K, Noordik E, van Dijk FJ, van der Klink JJ. Return to work perceptions and actual return to work in workers with common mental disorders. J Occup Rehabil. 2013 Jun;23(2):290-9. doi: 10.1007/s10926-012-9389-6.
PubMed 23124685Schultz IZ, Crook J, Meloche GR, Berkowitz J, Milner R, Zuberbier OA, Meloche W. Psychosocial factors predictive of occupational low back disability: towards development of a return-to-work model. Pain. 2004 Jan;107(1-2):77-85. doi: 10.1016/j.pain.2003.09.019.
PubMed 14715392Levesque CS, Williams GC, Elliot D, Pickering MA, Bodenhamer B, Finley PJ. Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors. Health Educ Res. 2007 Oct;22(5):691-702. doi: 10.1093/her/cyl148. Epub 2006 Nov 30.
PubMed 17138613Lorig, K., Stwart, A., Ritter, P., Gonzales, V., Laurent, D., & Lynch, J. Outcome measures for health education and other health care interventions. Thousand Oaks, CA: Sage Publications. 1996.
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part I). Health Promot Pract. 2005 Jan;6(1):37-43. doi: 10.1177/1524839904266790.
PubMed 15574526Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part II). Health Promot Pract. 2005 Apr;6(2):148-56. doi: 10.1177/1524839904266792.
PubMed 15855284Lorig K, Laurent DD, Plant K, Krishnan E, Ritter PL. The components of action planning and their associations with behavior and health outcomes. Chronic Illn. 2014 Mar;10(1):50-9. doi: 10.1177/1742395313495572. Epub 2013 Jul 9.
PubMed 23838837Broadbent E, Petrie KJ, Main J, Weinman J. The brief illness perception questionnaire. J Psychosom Res. 2006 Jun;60(6):631-7. doi: 10.1016/j.jpsychores.2005.10.020.
PubMed 16731240Morisky DE, DiMatteo MR. Improving the measurement of self-reported medication nonadherence: response to authors. J Clin Epidemiol. 2011 Mar;64(3):255-7; discussion 258-63. doi: 10.1016/j.jclinepi.2010.09.002. Epub 2010 Dec 8. No abstract available.
PubMed 21144706
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Self-management Course for Adults on Sick-leave; Outcomes in Registry Based Measures of Return to Work and Questionnaire Based Measures of Well-being and Quality of Life
- ClinicalTrials.gov ID
- NCT02136056
- Acronym / sponsor ID
- jos / auh_JOS_sfi-01
- Keywords
- Sick-leave, Return to work, Self-management, Self-efficacy, Quality of Life and Well-being, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, VIVE - The Danish Center for Social Science Research
- Study start
- Sep 2014
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 12 May 2014 (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 purpose of the current study is to determine the efficacy of a self-management course for workers on sick-leave as an add-on to standard rehabilitation care and follow-up (treatment as usual). Outcomes are registry based measures of return to work, and questionnaire based measures of well-being and quality of life.
We thus, hypothesize that the program will improve workers return to work rates and self-reported/psychological well-being.
Detailed description
The intervention course is a Danish adaptation of The Chronic Disease Self-Management Program (CDSMP), tailored towards workers on sick-leave. The original program has been developed by The Stanford Patient Education Research Center. The translation and adaptation has been conducted by The Danish Committee for Health Education.
Previous studies have examined the program with respect to specific chronic diseases (e.g., Arthritis), quality of life, well-being and health-care utilization, though non-otherwise specified workers on sick-leave and return work have not been examined before.
The framework of CDSMP is social-cognitive learning theory in which self-efficacy plays a central role.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management program (SMP) | Experimental | Behavioral: Self-management program (SMP)Participants in the experimental group receive six weekly group-sessions of self-management and patient education; specifically targeting self-management of the return to work process and disease symptoms. |
| Treatment as usual | No intervention | –Participants in the control-group receive standard rehabilitation care and follow-up in the job-center. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Insured persons who receive sick-leave compensation from the Danish State
- Persons who are listed as sick from a job
- Persons who have been categorized as "2 - risk" or "3 - chronic" case by the job-center
- The health problem reflects a chronic or a long-term condition
- The person acknowledges a chronic or long-term condition
Key exclusion criteria (4 listed)
- Persons who are listed sick for more than 16 weeks
- Persons who are categorized as "1 - easy" by the job-center
- The person does not understand or speak danish
- History or signs of aggressive behavior and violence
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 |
|---|---|---|
| Self-management program (SMP)Also: Stanford patient educationA self-management course | Behavioural | Self-management program (SMP) |
Primary outcome
Return to work, duration
Time frame: Weekly from baseline till 1 year follow-up
DREAM-registry (supported by the Danish Ministry of Employment) combined with income/employment information from e-income (supported by the Danish Tax Authorities).
Well-being and Quality of life
Time frame: up to 5 month follow-up
WHO-5 Well-being and WHO Quality of Life/Satisfaction items (Bech, 2012)
5 secondary outcomes
Common mental disorders
Time frame: Baseline, post-intervention and 4,5 month follow-up
Disease self-efficacy scale
Time frame: Baseline, post-intervention and 4,5 month follow-up
Self-regulation (return to work)
Time frame: Baseline, post-intervention and 4,5 month follow-up
Self-management scale
Time frame: Baseline, post-intervention and 4,5 month follow-up
Illness Perception questionnaire
Time frame: Baseline, post-intervention and 4,5 month follow-up
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 8 Dec 2017.
- BackgroundBech, P. Clinical Psychometrics. Oxford: Wiley-Blackwell, 2012.
- Background: PubMed 15814580Christensen KS, Fink P, Toft T, Frostholm L, Ornbol E, Olesen F. A brief case-finding questionnaire for common mental disorders: the CMDQ. Fam Pract. 2005 Aug;22(4):448-57. doi: 10.1093/fampra/cmi025. Epub 2005 Apr 6.
- Background: PubMed 9817118Bjorner JB, Damsgaard MT, Watt T, Groenvold M. Tests of data quality, scaling assumptions, and reliability of the Danish SF-36. J Clin Epidemiol. 1998 Nov;51(11):1001-11. doi: 10.1016/s0895-4356(98)00092-4.
- Background: PubMed 22575393Amtmann D, Bamer AM, Cook KF, Askew RL, Noonan VK, Brockway JA. University of Washington self-efficacy scale: a new self-efficacy scale for people with disabilities. Arch Phys Med Rehabil. 2012 Oct;93(10):1757-65. doi: 10.1016/j.apmr.2012.05.001. Epub 2012 May 7.
- Background: PubMed 12389476Franche RL, Krause N. Readiness for return to work following injury or illness: conceptualizing the interpersonal impact of health care, workplace, and insurance factors. J Occup Rehabil. 2002 Dec;12(4):233-56. doi: 10.1023/a:1020270407044.
- Background: PubMed 23124685Nieuwenhuijsen K, Noordik E, van Dijk FJ, van der Klink JJ. Return to work perceptions and actual return to work in workers with common mental disorders. J Occup Rehabil. 2013 Jun;23(2):290-9. doi: 10.1007/s10926-012-9389-6.
- Background: PubMed 14715392Schultz IZ, Crook J, Meloche GR, Berkowitz J, Milner R, Zuberbier OA, Meloche W. Psychosocial factors predictive of occupational low back disability: towards development of a return-to-work model. Pain. 2004 Jan;107(1-2):77-85. doi: 10.1016/j.pain.2003.09.019.
- Background: PubMed 17138613Levesque CS, Williams GC, Elliot D, Pickering MA, Bodenhamer B, Finley PJ. Validating the theoretical structure of the Treatment Self-Regulation Questionnaire (TSRQ) across three different health behaviors. Health Educ Res. 2007 Oct;22(5):691-702. doi: 10.1093/her/cyl148. Epub 2006 Nov 30.
- BackgroundLorig, K., Stwart, A., Ritter, P., Gonzales, V., Laurent, D., & Lynch, J. Outcome measures for health education and other health care interventions. Thousand Oaks, CA: Sage Publications. 1996.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 15574526Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part I). Health Promot Pract. 2005 Jan;6(1):37-43. doi: 10.1177/1524839904266790.
- Background: PubMed 15855284Marks R, Allegrante JP, Lorig K. A review and synthesis of research evidence for self-efficacy-enhancing interventions for reducing chronic disability: implications for health education practice (part II). Health Promot Pract. 2005 Apr;6(2):148-56. doi: 10.1177/1524839904266792.
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.
Martin H Olesen, PhD study director
Aarhus University and Aarhus University Hospital
Jan Høgelund, PhD study chair
VIVE - The Danish Center for Social Science Research
Mimi Y Mehlsen, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management program (SMP) in people with Workers on Sick-leave, Insured by The Danish Welfare State, run by University of Aarhus at 1 site in Denmark.
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 8 inclusion and 4 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 8 Dec 2017. 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 Denmark. 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?
Return to work, duration (time frame: Weekly from baseline till 1 year follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136056, which also lists 15 linked publications.
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 8 Dec 2017.