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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by University of Aarhus
Sponsor:
Collaborators:
Aarhus University Hospital
The Danish National Centre For Social Research
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02136056
First received: May 8, 2014
Last updated: September 12, 2016
Last verified: September 2016
  Purpose

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.


Condition Intervention
Workers on Sick-leave, Insured by The Danish Welfare State
Behavioral: Self-management program (SMP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Common mental disorders [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    The CMDQ questionnaire i based on SCL-90 (Symptom Checklist) and measures somatization, health-anxiety, depression, anxiety and alcohol consumption (Christensen et al., 2005)

  • Disease self-efficacy scale [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    The University of Washington Self-efficacy scale, 6 item version (Amtmann et al., 2012)

  • Self-regulation (return to work) [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    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)

  • Self-management scale [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    A measure of six cognitive strategies which are taught at the course (Lorig et al., 1996)

  • Illness Perception questionnaire [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    A measure of 8 items measuring the threat of illness or disease (B-IPQ; Broadbent, Petrie, Main & Weinman, 2006)


Other Outcome Measures:
  • Health-care utilization [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    Items that measure utilization of health-care consultation (Lorig et al., 1996)

  • Medicine consumption [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    Generic items that measure consumption of medicines such as anti-depressants and anxiety medicine, use of pain killers and sleep pills

  • Adherence to treatment [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    Adherence to disease specific treatment (inspired by the MMAS-4; Morisky & DiMatteo, 2011)

  • Common symptoms [ Time Frame: Baseline, post-intervention and 4.5 month follow-up ]
    Pain, breath, being tired, sleep quality; measured by VAS scales (Lorig et al., 1996)

  • Decisional Balance (return to work) [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    Generic items that measures how the advantages and disadvantages of returning to work are balanced (Franche & Krause, 2002)

  • Return to work expectations [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    Generic items that measure expectations about returning to work (Niewenhuiksen, Noordik, van Dijk & van der Klink. 2013; Schultz et al., 20014)


Estimated Enrollment: 1200
Study Start Date: September 2014
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Stanford patient education
No Intervention: Treatment as usual
Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02136056

Contacts
Contact: Martin H Olesen, MSc, PhD +458716587 martin.olesen@psy.au.dk
Contact: Mimi Y Mehlsen, MSc, PhD +4587165874 mimim@psy.au.dk

Locations
Denmark
The Danish Comitee for Health Education Recruiting
Copenhagen, Denmark, 2100
Contact: Lea Hegaard, MSc    +4522662671    la@sundkom.dk   
Contact: Nicolaj H Faber, MSc    +4522671012    nhf@sundkom.dk   
Principal Investigator: Charan Nelander, MSc         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
The Danish National Centre For Social Research
Investigators
Study Director: Martin H Olesen, PhD Aarhus University and Aarhus University Hospital
Study Chair: Jan Høgelund, PhD The Danish National Centre For Social Research
Principal Investigator: Mimi Y Mehlsen, PhD University of Aarhus
  More Information

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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02136056     History of Changes
Other Study ID Numbers: auh_JOS_sfi-01
Study First Received: May 8, 2014
Last Updated: September 12, 2016

Keywords provided by University of Aarhus:
Sick-leave
Return to work
Self-management
Self-efficacy
Quality of Life and Well-being
Motivation

ClinicalTrials.gov processed this record on April 24, 2017