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

NCT ID: NCT02136056

Last Updated: 2017-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-08-01

Brief Summary

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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

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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.

Conditions

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Workers on Sick-leave, Insured by The Danish Welfare State

Keywords

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Sick-leave Return to work Self-management Self-efficacy Quality of Life and Well-being Motivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Self-management program (SMP)

Intervention Type BEHAVIORAL

A self-management course

Treatment as usual

Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self-management program (SMP)

A self-management course

Intervention Type BEHAVIORAL

Other Intervention Names

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Stanford patient education

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

VIVE - The Danish Center for Social Science Research

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin H Olesen, PhD

Role: STUDY_DIRECTOR

Aarhus University and Aarhus University Hospital

Jan Høgelund, PhD

Role: STUDY_CHAIR

VIVE - The Danish Center for Social Science Research

Mimi Y Mehlsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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The Danish Comitee for Health Education

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Bech, P. Clinical Psychometrics. Oxford: Wiley-Blackwell, 2012.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15814580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9817118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22575393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12389476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23124685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14715392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17138613 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 2748771 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15574526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15855284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23838837 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16731240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21144706 (View on PubMed)

Related Links

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http://www.patientuddannelse.info/jos.aspx

Web-page that describes the course

Other Identifiers

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auh_JOS_sfi-01

Identifier Type: -

Identifier Source: org_study_id