Effects of a Self-management Course for Adults on Sick-leave (jos)

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.

Study Overview

• Status: Completed
• Conditions: Workers on Sick-leave, Insured by The Danish Welfare State
• Intervention / Treatment: Behavioral: Self-management program (SMP)

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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • The Danish Comitee for Health Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Self-management program (SMP); A self-management course; Other Names: Stanford patient education
No Intervention: Treatment as usual; Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-care utilization	Items that measure utilization of health-care consultation (Lorig et al., 1996)	Baseline, post-intervention and 4,5 month follow-up
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital; VIVE - The Danish Center for Social Science Research
• Investigators: Study Director: Martin H Olesen, PhD, Aarhus University and Aarhus University Hospital; Study Chair: Jan Høgelund, PhD, VIVE - The Danish Center for Social Science Research; Principal Investigator: Mimi Y Mehlsen, PhD, University of Aarhus

Publications and helpful links

General Publications

• 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.
• Broadbent 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.
• Amtmann 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.
• Morisky 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.
• Marks 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.
• Marks 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.
• 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.
• Bjorner 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.
• Franche 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.
• Nieuwenhuijsen 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.
• Schultz 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.
• Levesque 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.
• Lorig, 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.
• Lorig 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: May 8, 2014
• First Submitted That Met QC Criteria: May 9, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Motivation; Self-efficacy; Self-management; Return to work; Sick-leave; Quality of Life and Well-being
• Other Study ID Numbers: auh_JOS_sfi-01