Workers on Sick-leave, Insured by The Danish Welfare State Clinical Trial
— josOfficial 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
| Verified date | September 2016 |
| Source | University of Aarhus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | August 1, 2016 |
| Est. primary completion date | June 1, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | The Danish Comitee for Health Education | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus | Aarhus University Hospital, The Danish National Centre For Social Research |
Denmark,
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* Note: There are 15 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Health-care utilization | Items that measure utilization of health-care consultation (Lorig et al., 1996) | Baseline, post-intervention and 4,5 month follow-up | |
| Other | Medicine consumption | Generic items that measure consumption of medicines such as anti-depressants and anxiety medicine, use of pain killers and sleep pills | Baseline, post-intervention and 4,5 month follow-up | |
| Other | Adherence to treatment | Adherence to disease specific treatment (inspired by the MMAS-4; Morisky & DiMatteo, 2011) | Baseline, post-intervention and 4,5 month follow-up | |
| Other | Common symptoms | Pain, breath, being tired, sleep quality; measured by VAS scales (Lorig et al., 1996) | Baseline, post-intervention and 4.5 month follow-up | |
| Other | Decisional Balance (return to work) | Generic items that measures how the advantages and disadvantages of returning to work are balanced (Franche & Krause, 2002) | Baseline, post-intervention and 4,5 month follow-up | |
| Other | Return to work expectations | Generic items that measure expectations about returning to work (Niewenhuiksen, Noordik, van Dijk & van der Klink. 2013; Schultz et al., 20014) | Baseline, post-intervention and 4,5 month follow-up | |
| Primary | 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). | Weekly from baseline till 1 year follow-up | |
| Primary | Well-being and Quality of life | WHO-5 Well-being and WHO Quality of Life/Satisfaction items (Bech, 2012) | up to 5 month follow-up | |
| Secondary | 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) | Baseline, post-intervention and 4,5 month follow-up | |
| Secondary | Disease self-efficacy scale | The University of Washington Self-efficacy scale, 6 item version (Amtmann et al., 2012) | Baseline, post-intervention and 4,5 month follow-up | |
| Secondary | 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) | Baseline, post-intervention and 4,5 month follow-up | |
| Secondary | Self-management scale | A measure of six cognitive strategies which are taught at the course (Lorig et al., 1996) | Baseline, post-intervention and 4,5 month follow-up | |
| Secondary | Illness Perception questionnaire | A measure of 8 items measuring the threat of illness or disease (B-IPQ; Broadbent, Petrie, Main & Weinman, 2006) | Baseline, post-intervention and 4,5 month follow-up |