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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Self-management program (SMP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-management program (SMP)<br>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. | Behavioral: Self-management program (SMP)<br>* A self-management course<br>* Other names: Stanford patient education;|
| No Intervention: Treatment as usual<br>Participants in the control-group receive standard rehabilitation care and follow-up in the job-center. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work, duration | DREAM-registry (supported by the Danish Ministry of Employment) combined with income/employment information from e-income (supported by the Danish Tax Authorities). | Weekly from baseline till 1 year follow-up | 
| Well-being and Quality of life | WHO-5 Well-being and WHO Quality of Life/Satisfaction items (Bech, 2012) | up to 5 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common mental disorders | The CMDQ questionnaire i based on SCL-90 (Symptom Checklist) and measures somatization, health-anxiety, depression, anxiety and alcohol consumption (Christensen et al., 2005) | Baseline, post-intervention and 4,5 month follow-up | 
| Disease self-efficacy scale | The University of Washington Self-efficacy scale, 6 item version (Amtmann et al., 2012) | Baseline, post-intervention and 4,5 month follow-up | 
| Self-regulation (return to work) | 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) | Baseline, post-intervention and 4,5 month follow-up | 
| Self-management scale | A measure of six cognitive strategies which are taught at the course (Lorig et al., 1996) | Baseline, post-intervention and 4,5 month follow-up | 
| Illness Perception questionnaire | A measure of 8 items measuring the threat of illness or disease (B-IPQ; Broadbent, Petrie, Main & Weinman, 2006) | Baseline, post-intervention and 4,5 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sick-leave, Return to work, Self-management, Self-efficacy, Quality of Life and Well-being, Motivation