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

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ClinicalTrials.gov Identifier: NCT02136056
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
Aarhus University Hospital
VIVE - The Danish Centre of Applied Social Science
Information provided by (Responsible Party):
University of Aarhus

May 8, 2014
May 12, 2014
December 8, 2017
September 2014
June 1, 2016   (Final data collection date for primary outcome measure)
  • 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)
Same as current
Complete list of historical versions of study NCT02136056 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • Physical functioning [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    Items from the Short Form SF-36 physical functioning sub-scale (Bjorner, Damsgaard, Watt, & Groenvold, 1998), VAS sliders!
  • 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)
  • Decisional balance (return to work) [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    Generic item that measures how the advantages and disadvantages of returning to work are balanced, VAS slider (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 (Nieuwenhuijsen, Noordik, van Dijk, & van der Klink, 2013; Schultz et al., 2004)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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, adherence to treatment [ 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, adherence to disease specific treatment (inspired by the MMAS-4; Morisky & DiMatteo, 2011), use of pain killers and sleep pills
  • Illness perception [ Time Frame: Baseline, post-intervention and 4,5 month follow-up ]
    Brief Illness Perception Questionnaire (B-IPQ; Broadbent, Petrie, Main & Weinman, 2006)
 
Effects of a Self-management Course for Adults on Sick-leave
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Workers on Sick-leave, Insured by The Danish Welfare State
Behavioral: Self-management program (SMP)
A self-management course
Other Name: Stanford patient education
  • 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.
    Intervention: Behavioral: Self-management program (SMP)
  • No Intervention: Treatment as usual
    Participants in the control-group receive standard rehabilitation care and follow-up in the job-center.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
1500
August 1, 2016
June 1, 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT02136056
auh_JOS_sfi-01
Yes
Not Provided
Not Provided
University of Aarhus
University of Aarhus
  • Aarhus University Hospital
  • VIVE - The Danish Centre of Applied Social Science
Study Director: Martin H Olesen, PhD Aarhus University and Aarhus University Hospital
Study Chair: Jan Høgelund, PhD VIVE - The Danish Centre of Applied Social Science
Principal Investigator: Mimi Y Mehlsen, PhD University of Aarhus
University of Aarhus
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP