Skip to main content
OpenTrials
Completed

NCT Number: NCT02136056

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Danish Comitee for Health Education

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-management program (SMP)

Behavioral

A self-management course

Other names: Stanford patient education

Primary outcomes

  1. 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).

  2. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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 outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • VIVE - The Danish Center for Social Science Research

Registry information

Official study 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

Acronym: jos

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 12, 2014
Registry last updated
Dec 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.