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Clinical Trials/NCT02136056
NCT02136056
Completed
Not Applicable

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

University of Aarhus1 site in 1 country600 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Workers on Sick-leave, Insured by The Danish Welfare State
Sponsor
University of Aarhus
Enrollment
600
Locations
1
Primary Endpoint
Well-being and Quality of life
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
August 1, 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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)

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).

Secondary Outcomes

  • 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)
  • 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)
  • Illness Perception questionnaire(Baseline, post-intervention and 4,5 month follow-up)

Study Sites (1)

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