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

Not Applicable

Completed

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

• Registration Number: NCT02136056
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-12
• Study Start: 2014-09
• Primary Completion: 2016-06-01
• Study Completion: 2016-08-01
• Status Verified: 2016-09
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-management program (SMP)	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.

Primary Outcome Measures

Name	Time	Method
Well-being and Quality of life	up to 5 month follow-up	WHO-5 Well-being and WHO Quality of Life/Satisfaction items (Bech, 2012)
Return to work, duration	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 Outcome Measures

Name	Time	Method
Self-regulation (return to work)	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	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)
Common mental disorders	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	Baseline, post-intervention and 4,5 month follow-up	The University of Washington Self-efficacy scale, 6 item version (Amtmann et al., 2012)
Illness Perception questionnaire	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)

Trial Locations

Locations (1)

The Danish Comitee for Health Education; 🇩🇰 Copenhagen, Denmark