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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02136056
Acronym
jos
Enrollment
600
Registered
2014-05-12
Start date
2014-09-30
Completion date
2016-08-01
Last updated
2017-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Sick-leave, Return to work, Self-management, Self-efficacy, Quality of Life and Well-being, Motivation

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.

Interventions

BEHAVIORALSelf-management program (SMP)

A self-management course

Sponsors

Aarhus University Hospital
CollaboratorOTHER
VIVE - The Danish Center for Social Science Research
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Return to work, durationWeekly from baseline till 1 year follow-upDREAM-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 lifeup to 5 month follow-upWHO-5 Well-being and WHO Quality of Life/Satisfaction items (Bech, 2012)

Secondary

MeasureTime frameDescription
Common mental disordersBaseline, post-intervention and 4,5 month follow-upThe 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 scaleBaseline, post-intervention and 4,5 month follow-upThe University of Washington Self-efficacy scale, 6 item version (Amtmann et al., 2012)
Self-regulation (return to work)Baseline, post-intervention and 4,5 month follow-upReturn 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 scaleBaseline, post-intervention and 4,5 month follow-upA measure of six cognitive strategies which are taught at the course (Lorig et al., 1996)
Illness Perception questionnaireBaseline, post-intervention and 4,5 month follow-upA measure of 8 items measuring the threat of illness or disease (B-IPQ; Broadbent, Petrie, Main & Weinman, 2006)

Other

MeasureTime frameDescription
Adherence to treatmentBaseline, post-intervention and 4,5 month follow-upAdherence to disease specific treatment (inspired by the MMAS-4; Morisky & DiMatteo, 2011)
Medicine consumptionBaseline, post-intervention and 4,5 month follow-upGeneric items that measure consumption of medicines such as anti-depressants and anxiety medicine, use of pain killers and sleep pills
Common symptomsBaseline, post-intervention and 4.5 month follow-upPain, breath, being tired, sleep quality; measured by VAS scales (Lorig et al., 1996)
Decisional Balance (return to work)Baseline, post-intervention and 4,5 month follow-upGeneric items that measures how the advantages and disadvantages of returning to work are balanced (Franche & Krause, 2002)
Return to work expectationsBaseline, post-intervention and 4,5 month follow-upGeneric items that measure expectations about returning to work (Niewenhuiksen, Noordik, van Dijk & van der Klink. 2013; Schultz et al., 20014)
Health-care utilizationBaseline, post-intervention and 4,5 month follow-upItems that measure utilization of health-care consultation (Lorig et al., 1996)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026