NCT02136056

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

December 8, 2017

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

May 8, 2014

Last Update Submit

December 7, 2017

Conditions

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

Keywords

Sick-leaveReturn to workSelf-managementSelf-efficacyQuality of Life and Well-beingMotivation

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Common mental disorders

    Baseline, post-intervention and 4,5 month follow-up

  • Disease self-efficacy scale

    Baseline, post-intervention and 4,5 month follow-up

  • Self-regulation (return to work)

    Baseline, post-intervention and 4,5 month follow-up

  • Self-management scale

    Baseline, post-intervention and 4,5 month follow-up

  • Illness Perception questionnaire

    Baseline, post-intervention and 4,5 month follow-up

Other Outcomes (6)

  • Health-care utilization

    Baseline, post-intervention and 4,5 month follow-up

  • Medicine consumption

    Baseline, post-intervention and 4,5 month follow-up

  • Adherence to treatment

    Baseline, post-intervention and 4,5 month follow-up

  • +3 more other outcomes

Study Arms (2)

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.

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.

Interventions

Self-management program (SMP)BEHAVIORAL

A self-management course

Also known as: Stanford patient education
Self-management program (SMP)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Danish Comitee for Health Education

Copenhagen, 2100, Denmark

Location

Related Publications (15)

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

    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.

    PMID: 15814580BACKGROUND

  • 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.

    PMID: 9817118BACKGROUND

  • 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.

    PMID: 22575393BACKGROUND

  • 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.

    PMID: 12389476BACKGROUND

  • 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.

    PMID: 23124685BACKGROUND

  • 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.

    PMID: 14715392BACKGROUND

  • 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.

    PMID: 17138613BACKGROUND

  • 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.

    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.

    PMID: 2748771BACKGROUND

  • 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.

    PMID: 15574526BACKGROUND

  • 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.

    PMID: 15855284BACKGROUND

  • 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.

    PMID: 23838837BACKGROUND

  • 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.

    PMID: 16731240BACKGROUND

  • 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.

    PMID: 21144706BACKGROUND

Related Links

MeSH Terms

Interventions

Self-Management

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Martin H Olesen, PhD

    Aarhus University and Aarhus University Hospital

    STUDY DIRECTOR

  • Jan Høgelund, PhD

    VIVE - The Danish Center for Social Science Research

    STUDY CHAIR

  • Mimi Y Mehlsen, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2014

First Posted

May 12, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

December 8, 2017

Record last verified: 2016-09

Locations

DK(1)